drugset / Trial / NCT00381134
Improving Outcomes in Patients With Kidney Disease Due to Diabetes
Phase 2
Completed
92 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
RandomizedParallel-groupDouble-blindTreatment
Summary
Kidney disease affects about one out of three people with diabetes mellitus, a common medical problem. Treatment of kidney disease with medications that lower blood pressure can slow the kidney disease but there is no known cure. This study is designed to test the hypothesis that certain combination-based blood pressure lowering regimens (of FDA approved medications) are better than single agent-based regimens for lowering blood pressure and further slowing or preventing progression of this incurable disease
Timeline
- Start
- 2003-07
- Primary completion
- —
- Completion
- 2006-12
Publications
- Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
- Crompton M, Ferguson JK, Ramnath RD, Onions KL, Ogier AS, Gamez M, Down CJ, Skinner L, Wong KH, Dixon LK, Sutak J, Harper SJ, Pontrelli P, Gesualdo L, Heerspink HL, Toto RD, Welsh GI, Foster RR, Satchell SC, Butler MJ. Mineralocorticoid receptor antagonism in diabetes reduces albuminuria by preserving the glomerular endothelial glycocalyx. JCI Insight. 2023 Mar 8;8(5):e154164. doi: 10.1172/jci.insight.154164.
- Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
- Srivastava A, Adams-Huet B, Vega GL, Toto RD. Effect of losartan and spironolactone on triglyceride-rich lipoproteins in diabetic nephropathy. J Investig Med. 2016 Aug;64(6):1102-8. doi: 10.1136/jim-2016-000102. Epub 2016 Jul 7.
- Van Buren PN, Adams-Huet B, Nguyen M, Molina C, Toto RD. Potassium handling with dual renin-angiotensin system inhibition in diabetic nephropathy. Clin J Am Soc Nephrol. 2014 Feb;9(2):295-301. doi: 10.2215/CJN.07460713. Epub 2014 Jan 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Losartan | Other / unclassified | 100 mg | Oral |
| Subject | Spironolactone | Small molecule | 25 mg | Oral |