Endothelin Receptor Antagonism in Proteinuric Nephropathy

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The number of people with kidney problems is increasing rapidly, related in part to the increasing prevalence of diabetes. Patients with kidney problems tend to have protein leaking into the urine (proteinuria). Both proteinuria and the kidney disease itself are associated with an increased risk of heart disease. Reducing proteinuria is an important treatment goal in people with kidney problems. Endothelin is a chemical produced both by blood vessels and the kidney. Higher than normal levels of endothelin are thought to contribute to progression of kidney disease and proteinuria. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') we can hopefully reduce both of these. The purpose of the study is to ascertain whether endothelin receptor antagonists improve kidney function and reduce proteinuria more so than other commonly used drugs.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborator: British Heart Foundation
• Treatments: cyclo(Trp-Asp-Pro-Val-Leu); Endothelin A Receptor Antagonists; Nifedipine

Criteria

Inclusion Criteria:

• Male or female

• Age 18-70

• Body mass index <35

• Blood pressure <160/110 mmHg

• CKD stage 2-5 as per the K/DOQI classification

• Proteinuria in one of the following categories: 0.3-1.5, >1.5-3.0, and >3.0-6.0 g/24hrs

• Normal serum albumin

Exclusion Criteria:

• Subject is below the age of legal consent, or is mentally or legally incapacitated

• History of multiple and/or severe allergic reactions to drugs (including study drugs), or food

• The subject has donated blood (450 ml) within the last 4 weeks

• Past or present drug or alcohol abuse including intravenous drug abuse at any time

• Participation in another clinical trial within 1 month

• Considered to be at high risk of HIV or hepatitis B

• Pregnant