CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Spironolactone +1 moredrug
Likely dose
Spironolactone 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00291720
NCT00291720Phase 2Completed

Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?

University Hospital Birmingham·interventional·Posted Feb 14, 2006·Updated May 21, 2008

In Brief

A Phase 2 clinical trial evaluating Spironolactone and Placebo for Chronic Kidney Disease and Cardiovascular Disease. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2006
Enrollment StartApr 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.4 years ago

Interventions

Spironolactonedrug

All patients receive a 4 week open labeled run in phase of 25mg spironolactone daily after which they are randomized to continue or receive matched placebo for 8 months.

Placebodrug

matching placebo