ASSESSMENT AND MANAGEMENT OF IgA NEPHROPATHY John Feehally

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ASSESSMENT AND MANAGEMENT OFIgA NEPHROPATHY
John Feehally
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IgA NEPHROPATHYThe commonest pattern of
glomerulonephritis in the world
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CLASSIFICATION OF GLOMERULONEPHRITIS
Histopathology
Clinical
Immune mechanisms
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CLASSIFICATION OF GLOMERULONEPHRITIS
Histopathology
Clinical
Immune mechanisms
Patterns established on light microscopy Membrano
us Membranoproliferative Focal segmental
glomerulosclerosis etc
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CLASSIFICATION OF GLOMERULONEPHRITIS
Histopathology
Clinical
Immune mechanisms
Patterns established on light microscopy Membrano
us Membranoproliferative Focal segmental
glomerulosclerosis etc
Patterns not diseases
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IgA1 deposition In the glomerular mesangium
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IgA NEPHROPATHY
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ASSESSMENT AND MANAGEMENT OFIgA NEPHROPATHY
Is IgA nephropathya single disease ?
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IgA NEPHROPATHYA pattern of glomerulonephritis
with many variations
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Recurrent visible haematuria Coincides with
mucosal infection
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Nephrotic syndrome
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Asymptomatic Haematuria / proteinuria
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CKD Proteinuria Hypertension Renal impairment
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HENOCH-SCH?NLEIN NEPHRITIS
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Henoch-Schonlein purpura
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SECONDARY IgA NEPHROPATHY
COMMONLY REPORTED ASSOCIATIONS Alcoholic liver
disease Celiac disease Ankylosing
spondylitis Reiters syndrome Uveitis Dermatitis
herpetiformis
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RECURRENT IgA NEPHROPATHY
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RECURRENT IgA NEPHROPATHY

Pooled published data 5 year follow up
Recurrence 38-60
Graft dysfunction due to recurrence 15
Graft loss due to recurrence 7
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RECURRENT IgA NEPHROPATHY

Pooled published data 5 year follow up
Recurrence 38-60
Graft dysfunction due to recurrence 15
Graft loss due to recurrence 7
Why does IgA nephropathy NOT always recur ?
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15-21
4.7
lt5
Percentage of patients with primary glomerular
disease
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15-21
Male gt Female
Male Female
4.7
lt5
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IgA NEPHROPATHYVariations in
Pathological pattern Clinical pattern
Transplant recurrence Epidemiological
patternPathogenesis
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IgA NEPHROPATHY
Not expect a single pathogenic mechanism to
lead to mesangial IgA deposition and injury

No proof that IgAN is a single disease
No proof that IgAN is the same disease in all
parts of the world
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ASSESSMENT AND MANAGEMENT OFIgA NEPHROPATHY
Can you predict which patients with IgA
nephropathywill get kidney failure?
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ASSESSMENT AND MANAGEMENT OFIgA NEPHROPATHY
Can you predict which patients with IgA
nephropathywill get kidney failure?CLINICAL
evidence
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PROGNOSIS IN IgA NEPHROPATHY
Rodicio 1982
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PROGNOSIS IN IgA NEPHROPATHY
20 ESRD _at_ 20 years
Rodicio 1982
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IgA NEPHROPATHY IN INDIA
CMC Vellore 1994-2003
Chacko B et al. Nephrology 2005 10 496
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IgA NEPHROPATHY IN INDIA
CMC Vellore 1994-2003 478 adults 55 -
Nephrotic syndrome at presentation 56 - Serum
creatinine gt 123 µmol/L at presentation
Chacko B et al. Nephrology 2005 10 496
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MACROSCOPIC HAEMATURIA AND PROGNOSIS IN IgA
NEPHROPATHY
Beukhof 1983
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LEAD TIME BIAS IN DIAGNOSIS OF IgA NEPHROPATHY
Geddes CC et al. NDT 2003 18 1541
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ISOLATED NON-VISIBLE HAEMATURIA IN IgA NEPHROPATHY
How benign is it ? Cohort study Toronto 286
patients
Proteinuria lt 0.2 g/24hr Normal BP
Non-visible haematuria
plus
Bartosik et al. AJKD 2001 38 728
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ISOLATED MICROSCOPIC HAEMATURIA IN IgA NEPHROPATHY
How benign is it ? Cohort study Toronto 286
patients
Proteinuria lt 0.2 g/24hr Normal BP
Microscopic haematuria
plus
10 year risk of deterioration in renal
function ZERO
Bartosik et al. AJKD 2001 38 728
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ISOLATED NON-VISIBLE HAEMATURIA IN IgA NEPHROPATHY
How benign is it ? Cohort study Hong Kong
Non-visible haematuria
Proteinuria lt 0.4 g/24hr
plus
During 7 years follow up, 44 had a clinical
event 33 proteinuria 26 hypertension 7
renal impairment
Szeto C et al Am J Med 2001 110434
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OUTCOME AND AVERAGE FOLLOW-UP PROTEINURIA IN IgA
NEPHROPATHY
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REMISSION OF PROTEINURIA IMPROVES PROGNOSIS IN
IgA NEPHROPATHY
Time-average proteinuria 1 - lt 1g/24h 2 1-2
g/24h 3 2-3g/24h 4 - gt3g/24h
Reich H et al. JASN 2007 18 3177
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ASSESSMENT AND MANAGEMENT OFIgA NEPHROPATHY
Can you predict which patients with IgA
nephropathywill get kidney failure?PATHOLOGICA
L evidence
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A CLINICO-PATHOLOGICAL CLASSIFICATION FOR IgA
NEPHROPATHY

• Does pathology add prognostic information
• .. to clinical data at time of biopsy ?
• .. to clinical data during follow up ?

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A CLINICO-PATHOLOGICAL CLASSIFICATION FOR IgA
NEPHROPATHY

• Does pathology add prognostic information
• .. to clinical data at time of biopsy ?
• .. to clinical data during follow up ?

Perhaps the biopsy is only useful to establish
the diagnosis of IgAN ?
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PATHOLOGICAL CLASSIFICATIONS IN RENAL DISEASE

• Are usually based on expert opinion
• ... and pre-conceived ideas of what lesions are
  important

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OXFORD CLASSIFICATION OF IgA NEPHROPATHY

• A different way
• Approach the problem with an open mind
• With an international consensus group
• Study all histological lesions
• Test reproducibility independence
• Then test correlations with outcome

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SCORING OF SELECTED PATHOLOGY FEATURES
Mesangial hypercellularity - in gt or lt50 of
glomeruli M0 or M1 Endocapillary
hypercellularity present/absent E0 or
E1 Segmental sclerosis/adhesions
present/absent S0 or S1 Tubular
atrophy/interstitial fibrosis 0-25, 26-50,
gt50 T0 or T1 or T2
Each can be scored easily in routine clinical
practice
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PREDICTIVE SIGNIFICANCE OF PATHOLOGY FEATURES
IN IgA NEPHROPATHY
M E S T Each adds predictive value to
. Initial clinical features Follow up clinical
features
In all ages and races studied
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VALIDATION STUDIES FOR THE OXFORD
CLASSIFICATION OF IgAN
M E S T
Macedonia 2010 98
USA 2011 54 -
Japan 2011 161 children -
France 2011 183 -
USA, Canada 2011 187 adults children
China 2011 410 -
Japan 2011 702 - -
Sweden 2012 99 -
Korea 2012 197 -
6/10 7/10 6/10 10/10
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WHAT NEXT ?
Validation studies Work towards combining
pathology and clinical elements to produce a
single risk score There is now the
opportunity to design smaller, shorter RCTs
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ASSESSMENT AND MANAGEMENT OFIgA NEPHROPATHY
How good is the evidence to guide the treatment
of IgA nephropathy ?
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KI Supplements 2012 2(2) 1-274
CLINICAL PRACTICE GUIDELINE FOR GLOMERULONEPHRITIS
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Examples of Rating Guideline Recommendations
QUALITY of Supporting Evidence is shown as A, B,
C or D
Level 1 We recommend. Most patients should receive the recommended course of action 1A Supported by evidence from high quality RCTs
Level 2 We suggest Different choices will be appropriate for different patients. Each patient needs help to arrive at a management decision appropriate for them 2D No RCTs Supported by limited observational data
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Examples of Rating Guideline Recommendations
QUALITY of Supporting Evidence is shown as A, B,
C or D
Level 1 We recommend. Most patients should receive the recommended course of action 1A Supported by evidence from high quality RCTs
Level 2 We suggest Different choices will be appropriate for different patients. Each patient needs help to arrive at a management decision appropriate for them 2D No RCTs Supported by limited observational data
Of 10 recommendations or suggestions in the IgA
Nephropathy guideline Only 2 (20) are 1A or 1B
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Clinical Practice Guideline for Glomerulonephritis

• . will not tell you what to do for every
  difficult patient in every situation

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Clinical Practice Guideline for Glomerulonephritis

• . will not tell you what to do for every
  difficult patient in every situation
• The Guideline is not there to give you expert
  advice about an individual problem case

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Clinical Practice Guideline for Glomerulonephritis

• . will not tell us what to do for every
  difficult patient in every situation
• .will remind us what we know

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Clinical Practice Guideline for Glomerulonephritis

• . will not tell us what to do for every
  difficult patient in every situation
• .will remind us what we know
• .will remind us what we do not know

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ASSESSMENT AND MANAGEMENT OFIgA NEPHROPATHY
Should I treat this patient with IgA
nephropathy ?
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TREATMENT DECISIONS IN IgA NEPHROPATHY
Non-visible haematuria
Visible haematuria
Acute kidney injury
Crescentic IgA nephropathy
Proteinuria gt 1g/day
Nephrotic syndrome
Hypertension
Progressive fall in GFR
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TREATMENT DECISIONS IN IgA NEPHROPATHY
Microscopic haematuria
Macroscopic haematuria
Acute kidney injury
Crescentic IgA nephropathy
Proteinuria gt 1g/day
Nephrotic syndrome
Hypertension
Progressive fall in GFR
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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY

Recurrent Macroscopic Haematuria No role for
antibiotics No role for tonsillectomy
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TREATMENT DECISIONS IN IgA NEPHROPATHY
Microscopic haematuria
Macroscopic haematuria
Acute kidney injury
Proteinuria gt 1g/day
Nephrotic syndrome
Hypertension
Progressive renal insufficiency
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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY
Macroscopic Haematuria with acute renal
failure Renal biopsy is mandatory if not
improve in 2-3 days with supportive measures


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AKI WITH VISIBLE HAEMATURIA IN IgA NEPHROPATHY

9 published reports 84 patients
How common ? AKI in 38 (4/11) of visible
haematuria episodes (Praga 1985) Much less
common in most other reports How important are
crescents ? Crescents often seen, but in lt20 of
glomeruli and usually not the cause of AKI
Moreno J et al. CJASN 2012 7 175
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AKI WITH VISIBLE HAEMATURIA IN IgA NEPHROPATHY

9 published reports 84 patients
Recovery of renal function ? Most reports (29
patients) 100 have complete recovery of renal
function Two reports (55 patients) only 73
full recovery
Moreno J et al. CJASN 2012 7 175
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AKI WITH VISIBLE HAEMATURIA IN IgA NEPHROPATHY

Recovery of renal function ? Full recov
One centre in Spain (52 patients)
Full recovery less likely Older age Duration
of visible haematuria (mean 15 vs 36 days) Peak
sCr (7.1 vs 309 mg/dL) Tubular necrosis Tubular
red cell casts Interstitial fibrosis
Moreno J et al. CJASN 2012 7 175
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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY
Macroscopic Haematuria with acute renal
failure Renal biopsy is mandatory if not
improve in 2-3 days with supportive measures


Acute Tubular Necrosis Supportive measures only
Crescentic IgA nephropathy Immunosuppression may
be appropriate
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TREATMENT DECISIONS IN IgA NEPHROPATHY
Microscopic haematuria
Macroscopic haematuria
Acute renal failure
Crescentic IgA nephropathy
Proteinuria gt 1g/day
Nephrotic syndrome
Hypertension
Progressive renal insufficiency
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CRESCENTIC GLOMERULONEPHRITIS
Renal outcome with best known treatment
Renal survival 1 year 5
years Systemic vasculitis 80 75 Goodpastu
res 70 50 Crescentic IgA
nephropathy 50 20
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TREATMENT FOR CRESCENTIC IgA NEPHROPATHY
A number of recent optimistic reports -
Corticosteroids Cyclophosphamide Small lt
20 patients Selection criteria variable All are
anecdotal
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TREATMENT FOR CRESCENTIC IgA NEPHROPATHY

Definition? More than just a few crescents
Rapidly progressive renal failure

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TREATMENT FOR CRESCENTIC IgA NEPHROPATHY

Definition? More than just a few crescents
Rapidly progressive renal failure

Which patients respond ? Treat if crescents
other active glomerular damage AND no chronic
or irreversible changes
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TREATMENT FOR CRESCENTIC IgA NEPHROPATHY
If immunosuppression is indicated INDUCTION Pre
dnisolone 0.5-1mg/kg/day Cyclophosphamide
2mg/kg/day MAINTENANCE Prednisolone in
reducing dosage Azathioprine
2mg/kg/day plasma exchange unproven

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TREATMENT FOR CRESCENTIC IgA NEPHROPATHY
If immunosuppression is indicated INDUCTION Pre
dnisolone 0.5-1mg/kg/day Cyclophosphamide
2mg/kg/day MAINTENANCE Prednisolone in
reducing dosage Azathioprine
2mg/kg/day plasma exchange unproven

An RCT is badly needed . and will be difficult
to achieve
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TREATMENT DECISIONS IN IgA NEPHROPATHY
Microscopic haematuria
Macroscopic haematuria
Acute renal failure
Crescentic IgA nephropathy
Proteinuria gt 1g/day
Nephrotic syndrome
Hypertension
Progressive renal insufficiency
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NEPHROTIC-RANGE PROTEINURIA IN IgA NEPHROPATHY
IgAN and nephrotic range proteinuria N
233 More likely to have normoalbuminaemia than
minimal change, FSGS, or membranous
Nephrotic-range proteinuria and serum albumin gt
35 g/l 95.8 specificity for IgAN
Chen M et al. NDT 2011 26 1247
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NEPHROTIC SYNDROME IN IgA NEPHROPATHY
n 100 mean follow up 45 months Complete
remission 48 Partial remission 32 No
remission 20 Spontaneous remission 24
PRIMARY END POINT - DOUBLE SERUM
CREATININE 24 More likely if partial or no
remission
Kim J-K et al. CJASN 2012 7 247
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NEPHROTIC SYNDROME IN IgA NEPHROPATHY
n 100 Mean follow up 45 months
plt0.001
Kim J-K et al. CJASN 2012 7 247
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NEPHROTIC SYNDROME IN IgA NEPHROPATHY
100
885
Plt0.001
Kim J-K et al. CJASN 2012 7 247
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NEPHROTIC SYNDROME MICROSCOPIC HAEMATURIA
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NEPHROTIC SYNDROME MICROSCOPIC HAEMATURIA
Corticosteroids complete remission of nephrotic
syndrome Microscopic haematuria persists
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Two common glomerular diseases coincide
Minimal change nephrotic syndrome
IgA nephropathy
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NEPHROTIC SYNDROME IN IgA NEPHROPATHY
Minimal change Mesangial hypercellularity Gl
omerulosclerosis
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NEPHROTIC SYNDROME IN IgA NEPHROPATHY
Randomised controlled trial
n 34 Prednisolone for 4 months 40-60 mg
daily halved after 8 weeks Follow up 38 months

Response of proteinuria only in those with
minor histological changes
Lai - Clin Neph 1986 26174
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NEPHROTIC SYNDROME IN IgA NEPHROPATHY
Minimal change Mesangial hypercellularity Glomer
ulosclerosis
The response to corticosteroids in minimal change
does not justify their use in all IgAN with
nephrotic syndrome
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TREATMENT DECISIONS IN IgA NEPHROPATHY
Microscopic haematuria
Macroscopic haematuria
Acute kidney injury
Crescentic IgA nephropathy
Proteinuria gt 1g/day
Nephrotic syndrome
Hypertension
Progressive fall in GFR
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TREATMENT DECISIONS IN IgA NEPHROPATHY
Non-visible haematuria
Visible haematuria
Acute kidney injury
Crescentic IgA nephropathy
Proteinuria gt 1g/day
Nephrotic syndrome
Hypertension
Progressive fall in GFR
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PUBLISHED TREATMENT TRIALS IN IgA NEPHROPATHY
Often underpowered Often insufficient follow
up for hard endpoints Most use clinical entry
criteria Some have patients beyond the point of
no return
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TREATMENT OPTIONS FOR PROGRESSIVE IgA NEPHROPATHY
Blood pressure control Renin-angiotensin
blockade Corticosteroids Other
immunosuppressives
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TREATMENT OPTIONS FOR PROGRESSIVE IgA NEPHROPATHY
Blood pressure control Renin-angiotensin
blockade Corticosteroids Other
immunosuppression
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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY

Target Blood Pressure Proteinuria lt 1g/24hr
130/80 Proteinuria gt 1g/24hr 125/75
RAS Blockade Proteinuria gt 1g/24hr
125/75 Combination therapy ?
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EFFECT OF ACE INHIBITOR PLUS ARB ON PROTEINURIA
IN IgA NEPHROPATHY META-ANALYSIS

6 studies 109 patients
Cheng J et al. Int J Clin Pract 2012 66 917
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EFFECT OF ACE INHIBITOR PLUS ARB ON PROTEINURIA
IN IgA NEPHROPATHY META-ANALYSIS

6 studies 109 patients
No effect on GFR but Study duration 2-12
months
Cheng J et al. Int J Clin Pract 2012 66 917
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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY

Target Blood Pressure Proteinuria lt 1g/24hr
130/80 Proteinuria gt 1g/24hr 125/75
SALT RESTRICTION
RAS Blockade Proteinuria gt 1g/24hr
125/75 Combination therapy ?
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DIETARY SODIUM RESTRICTION AMPLIFIES EFFECTS OF
RAS BLOCKADE ON PROTEINURIA

Lisinopril 40mg/day Valsartan
320mg/day Sodium intake 50 or 200 mmol/day
Slagman M et al. BMJ 2011
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DIETARY SODIUM RESTRICTION AMPLIFIES EFFECTS OF
RAS BLOCKADE ON PROTEINURIA

Lisinopril 40mg/day Valsartan
320mg/day Sodium intake 50 or 200 mmol/day
Systolic BP
Diastolic BP
Slagman M et al. BMJ 2011
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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY

Proteinuria gt 1g/day hypertension
Only if BP target achieved and proteinuria
still gt1g/24 hr consider corticosteroids,
immunosuppressive regimens
What is the evidence these regimens are effective
in these circumstances ?
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TREATMENT OPTIONS FOR PROGRESSIVE IgA NEPHROPATHY
Blood pressure control Renin-angiotensin
blockade Corticosteroids Other
immunosuppression
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CORTICOSTEROID TREATMENT FOR IgA NEPHROPATHY
Randomised controlled trial serum creatinine lt
130 µmol/L


Survival without end point - doubling of serum
creatinine

Pozzi C et al Lancet 1999 353 883 - JASN
2004 15 157
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CORTICOSTEROID TREATMENT IN IgA NEPHROPATHY
Randomised controlled trial serum creatinine lt
133 µmol/L
n 86 creatinine lt 133 µmol/l - proteinuria
1-3.5g/24hr Regimen methylprednisolone 1g iv
x3 at 1,3,5 months plus prednisolone 0.5
mg/kg/alt days for 6 months No important side
effects - no study drop outs
Pozzi C et al Lancet 1999 353 883 - JASN
2004 15 157
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CORTICOSTEROID TREATMENT IN IgA NEPHROPATHY
Randomised controlled trial serum creatinine lt
133 µmol/L
n 103 2 year treatment regimen
Prednisolone 20mg od reducing to 5mg by 6
months
Antiproteinuric effect but no effect on renal
function
Katafuchi AJKD 2003 41972
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BLOOD PRESSURE CONTROL IN IgA NEPHROPATHY TRIALS
Corticosteroids Pozzi
Katafuchi
BP (mm Hg) 160 150 140 130 120 110 100 90
80 70 60
NKF Recommendation 125/75
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CORTICOSTEROIDS PLUS ACE INHIBITOR IN
PROTEINURIC IgA NEPHROPATHY


TWO SIMILAR STUDIES Proteinuria gt 1g/24h - GFR gt
50 ml/min
Continuous ACE inhibitor oral CORTICOSTEROIDS
for 6-8 months
Follow up 2 years (China), 5 years
(Italy) Well maintained BP
Lv J et al. 2009 AJKD 53 26 Manno C et al. NDT
2009 24 3694
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BLOOD PRESSURE CONTROL IN IgA NEPHROPATHY TRIALS
Corticosteroids Pozzi
Katafuchi Manno
Lv
BP (mm Hg) 160 150 140 130 120 110 100 90
80 70 60
JNC Recommendation 125/75
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CORTICOSTEROIDS PLUS ACE INHIBITOR IN
PROTEINURIC IgA NEPHROPATHY


ESRD STEROIDS CONTROL ITALY
1/48 8/49 CHINA 1/30
7/33
Statistically significant
Lv J et al. 2009 AJKD 53 26 Manno C et al. NDT
2009 24 3694
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CORTICOSTEROIDS PLUS ACE INHIBITOR IN
PROTEINURIC IgA NEPHROPATHY


STEROIDS CONTROL ITALY 1/48
8/49 CHINA 1/30 7/33
Statistically significant
But.. achieved ACE inhibitor dose rather low
Lv J et al. 2009 AJKD 53 26 Manno C et al. NDT
2009 24 3694
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CORTICOSTEROIDS PLUS ACE INHIBITOR IN
PROTEINURIC IgA NEPHROPATHY


STEROIDS CONTROL ITALY 1/48
8/49 CHINA 1/30 7/33
Statistically significant
But.. neither study had a run-in period
Lv J et al. 2009 AJKD 53 26 Manno C et al. NDT
2009 24 3694
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TREATMENT OPTIONS FOR PROGRESSIVE IgA NEPHROPATHY
Blood pressure control Renin-angiotensin
blockade Corticosteroids Other
immunosuppression
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IMMUNOSUPPRESSIVE TREATMENT FOR PROGRESSIVE IgA
NEPHROPATHY
NO ROLE FOR Cyclophosphamide
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BLOOD PRESSURE CONTROL IN IgA NEPHROPATHY TRIALS
Corticosteroids Pozzi
Katafuchi Manno
Lv
BP (mm Hg) 160 150 140 130 120 110 100 90
80 70 60
Ballardie Corticosteroids Cyclophosphamide

JNC Recommendation 125/75
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IMMUNOSUPPRESSIVE TREATMENT FOR PROGRESSIVE IgA
NEPHROPATHY
NO ROLE FOR Cyclophosphamide What about
Mycophenolate
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BLOOD PRESSURE CONTROL IN IgA NEPHROPATHY TRIALS
Corticosteroids Pozzi
Katafuchi Manno
Lv
Mycophenolate Maes Tang
BP (mm Hg) 160 150 140 130 120 110 100 90
80 70 60
Ballardie Corticosteroids Cyclophosphamide

JNC Recommendation 125/75
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MYCOPHENOLATE IN IgA NEPHROPATHY
Benefit BP achieved ACE
inhibitors number of patients BELGIUM Maes
2004 34 None 125/73 100 salt
restricted HONG KONG Tang 2005
40 ESRD 122/71 100 reduced

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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY

Uncertainty

• The role of corticosteroids and
  immunosuppressives
• after tight BP control and maximal RAS blockade ?
• The effect of ancestry on treatment responses

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Study Design
Optimal supportive therapy for 6 months (ACEi,
ARB, target BP lt 125/75 mm Hg, Statin, etc.)
Run-in Phase (6 Months)
Responder
Drop-Out
Non-Responder Proteinuria gt0.75 g/d
RANDOMISATION
Study-Phase (3 Years)
Optimal supportive
Optimal supportive Immunosuppression
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Recruitment-Update STOP IgAN - Status 28.2.2011 -
Study patients n356
IgAN patients
Randomised n127
Follow-up
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TREATMENT RECOMMENDATIONS FOR IgA NEPHROPATHY
We are still short of evidence .. So there
is room for your own opinion ..