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IRMA-2 Trial ( IR besartan in M icro A lbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 3

IRMA-2 Trial ( IR besartan in M icro A lbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 345:870-878, 2001 Edmund J. Lewis, M.D. Muehrcke Family Professor of Nephrology Section of Nephrology Rush University Medical Center Chicago, IL. Definitions IRMA-2.

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IRMA-2 Trial ( IR besartan in M icro A lbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 3

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  1. IRMA-2 Trial (IRbesartan in MicroAlbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 345:870-878, 2001 Edmund J. Lewis, M.D. Muehrcke Family Professor of Nephrology Section of Nephrology Rush University Medical Center Chicago, IL

  2. DefinitionsIRMA-2 Measure of Albuminuria: • Overnight urine albumin for 3 consecutive days • AER 20-200 µG/min in 2 of 3 consecutive overnight urine samples • Urine albumin determined by nephelometry Primary efficacy measure: • Time to event from baseline visit to overt nephropathy (AER >200 µG/min and at least 30% higher than baseline on 2 consecutive visits).

  3. Secondary OutcomesIRMA-2 • Changes in level of albuminuria • Restoration of normal albumin excretion rate AER <20 µG/min) by the time of the last visit

  4. Some relevant points about studying microalbumunuria. (CSG: Pilot trial of sulodexide in microalbuminuria associated with type 2 diabettes)

  5. 24 Hr Albumin ExcretionvsMean Albumin/Creatinine Ratio (MACR) (3 Consecutive First Morning Voids)

  6. 24 Hr Albumin/Creatinine RatiovsMean Albumin/Creatinine Ratio (MACR) (3 Consecutive First Morning Voids)

  7. Variance in Albumin Parameters

  8. Within Patient Variation in MACR (3 Consecutive First Morning Voids) Average CV of 3 consecutive voids = 33%

  9. IRMA-2 Trial Irbesartan

  10. IRMA-2 Trial Change in Albumin Excretion

  11. IRMA-2 Trial Unadjusted hazard ratio for overt diabetic nephropathy HR 95% CI P irbesartan 150 mg 0.61 0.34-1.08 <0.08 irbesartan 300 mg 0.30 0.14-0.61 <0.001 Adjusted hazard ratio (baseline AER, BP) irbesartan 150 mg 0.56 0.31-0.99 0.05 irbesartan 300 mg 0.32 0.15-0.65 <0.001

  12. IRMA-2 TrialH.H.Parving et al, NEJM 345:870-878, 2001

  13. IRMA-2 Trial Restoration of Normoalbuminuria

  14. IRMA-2 Trial Mean Arterial Blood Pressure

  15. Conclusions IRMA-2 • Irbesartan was effective in diminishing the rate of progression from “microalbuminuria” to “overt nephropathy” • This effect was dose dependent • This study did not document the long-term durability of the result. • Taken with the results of IDNT, this effect appeared to be a valid surrogate in this patient population.

  16. Potential End Points For Study of Microalbuminuria in Type 1 or Type 2 diabetes mellitus • decreased albumin excretion rate • decreased progression from “microalbuminuria” (albumin excretion <300 mg/day) to overt nephropathy (>300 mg/day) • regression of albuminuria (normalize or “significantly reduce”

  17. Redefining the Categories of Diabetic Nephropathy 0 30 300 mg/d Normal Microalbuminuria Overt ACEi ARB Normal Early diabetic glomerulopathy Overt New Therapies

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