drugset / Trial / NCT00280215
Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria
Phase 3
Withdrawn
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This study will test the effectiveness of two medications: ACEI (angiotensin converting enzyme inhibitor)and ARB (angiotensin receptor blocker) in reducing the renal injury induced by hyperoxaluria in patients with Primary Hyperoxaluria. Hypothesis: Calcium oxalate crystal deposition in the kidney causes inflammation and resulting injury to kidney tissue. Angiotensin blockade will improve these changes, thus slowing the progression of renal insufficiency in patients with Primary Hyperoxaluria.
Timeline
- Start
- 2007-12
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
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- Background Khan SR, Shevock PN, Hackett RL. Urinary enzymes and calcium oxalate urolithiasis. J Urol. 1989 Sep;142(3):846-9. doi: 10.1016/s0022-5347(17)38928-0.
- Background Lieske JC, Monico CG, Holmes WS, Bergstralh EJ, Slezak JM, Rohlinger AL, Olson JB, Milliner DS. International registry for primary hyperoxaluria. Am J Nephrol. 2005 May-Jun;25(3):290-6. doi: 10.1159/000086360. Epub 2005 Jun 15.
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- Background Toblli JE, Ferder L, Stella I, Angerosa M, Inserra F. Protective role of enalapril for chronic tubulointerstitial lesions of hyperoxaluria. J Urol. 2001 Jul;166(1):275-80.
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- Background Taal MW, Brenner BM. Combination ACEI and ARB therapy: additional benefit in renoprotection? Curr Opin Nephrol Hypertens. 2002 Jul;11(4):377-81. doi: 10.1097/00041552-200207000-00001.
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- Background Kavanagh JP, Jones L, Rao PN. Calcium oxalate crystallization kinetics studied by oxalate-induced turbidity in fresh human urine and artificial urine. Clin Sci (Lond). 2000 Feb;98(2):151-8.
- Background Fan J, Chandhoke PS. Examination of crystalluria in freshly voided urines of recurrent calcium stone formers and normal individuals using a new filter technique. J Urol. 1999 May;161(5):1685-8.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | LISINOPRIL ANHYDROUS | Small molecule | 0.15 mg/kg | — |
| Comparator | LISINOPRIL ANHYDROUS | Small molecule | 10 mg | — |
| Comparator | Losartan | Other / unclassified | 0.7 mg/kg | — |
| Comparator | Losartan | Other / unclassified | 50 mg | — |