drugset / Trial / NCT00143949
Renin Angiotensin System Study (RASS/B-RASS)
Phase 2
Completed
285 enrolled
Michael Mauer, MD
Canadian Institutes of Health Research (CIHR) · collabMerck Frosst Canada Ltd. · collabMerck Sharp & Dohme LLC · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupQuadruple-blind
Summary
To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.
Timeline
- Start
- 1997-03
- Primary completion
- 2007-03
- Completion
- 2008-05
Publications
- Background Mauer M, Zinman B, Gardiner R, Drummond KN, Suissa S, Donnelly SM, Strand TD, Kramer MS, Klein R, Sinaiko AR. ACE-I and ARBs in early diabetic nephropathy. J Renin Angiotensin Aldosterone Syst. 2002 Dec;3(4):262-9. doi: 10.3317/jraas.2002.048.
- Limonte CP, Prince DK, Hoofnagle AN, Galecki A, Hirsch IB, Tian F, Waikar SS, Looker HC, Nelson RG, Doria A, Mauer M, Kestenbaum BR, de Boer IH. Associations of Biomarkers of Tubular Injury and Inflammation with Biopsy Features in Type 1 Diabetes. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):44-55. doi: 10.2215/CJN.0000000000000333. Epub 2023 Oct 23.
- Robiner WN, Strand TD, Mauer M; Renin Angiotensin System Study (RASS) Group. Adherence and renal biopsy feasibility in the Renin Angiotensin-System Study (RASS) primary prevention diabetes trial. Diabetes Res Clin Pract. 2013 Oct;102(1):25-34. doi: 10.1016/j.diabres.2013.06.004. Epub 2013 Sep 17.
- Harindhanavudhi T, Mauer M, Klein R, Zinman B, Sinaiko A, Caramori ML; Renin Angiotensin System Study (RASS) group. Benefits of Renin-Angiotensin blockade on retinopathy in type 1 diabetes vary with glycemic control. Diabetes Care. 2011 Aug;34(8):1838-42. doi: 10.2337/dc11-0476. Epub 2011 Jun 29.
- Klein R, Myers CE, Klein BE, Zinman B, Gardiner R, Suissa S, Sinaiko AR, Donnelly SM, Goodyer P, Strand T, Mauer M. Relationship of blood pressure to retinal vessel diameter in type 1 diabetes mellitus. Arch Ophthalmol. 2010 Feb;128(2):198-205. doi: 10.1001/archophthalmol.2009.391.
- Mauer M, Zinman B, Gardiner R, Suissa S, Sinaiko A, Strand T, Drummond K, Donnelly S, Goodyer P, Gubler MC, Klein R. Renal and retinal effects of enalapril and losartan in type 1 diabetes. N Engl J Med. 2009 Jul 2;361(1):40-51. doi: 10.1056/NEJMoa0808400.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enalapril | Other / unclassified | 20 mg | — |
| Subject | Losartan | Other / unclassified | 100 mg | — |