CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 148 target
Drug / intervention
supportive therapy with: ACE-inhibitor / ARB / Statin +1 moredrug
Likely dose
supportive therapy with: ACE-inhibitor / ARB / Statin 60 mlfrom 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/NCT00554502
NCT00554502Phase 3Completed

Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy

RWTH Aachen University·interventional·Posted Nov 7, 2007·Updated Sep 22, 2015

In Brief

A Phase 3 clinical trial evaluating supportive therapy with: ACE-inhibitor / ARB / Statin and supportive and immunosuppressive therapy for IgA Nephropathy. Completed, enrolled 148 participants across 34 sites.

Detailed Summary

* Evaluation of the efficacy of an immunosuppressive therapy added to a comprehensive supportive therapy to induce a clinical remission in patients at risk for progressive IgAN * Investigation of differences between the treatments regarding the number of patients loosing more than 15 ml/min of GFR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIgA Nephropathy
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2007
Enrollment StartFeb 1, 2008
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 18.7 years ago

Interventions

supportive therapy with: ACE-inhibitor / ARB / Statindrug

* Antihypertensive therapy with a target blood pressure below 125/75 mmHg (following current clinical guidelines). * ACE-inhibitors (ARB when an ACE-inhibitor is not tolerated) * Other antihypertensive medications depending on the clinical decision and following current guidelines. * Statin therapy * Dietary counseling for a low-sodium diet and, if GFR is below 60 ml/min, for a protein intake of 0.8 g/kg/day.

supportive and immunosuppressive therapydrug

* supportive therapy as outlined above * depending on GFR: * methylprednisolone and prednisolone * cyclophosphamide and prednisolone; after 3 months azathioprine with prednisolone * Concomitant medication with the immunosuppressive treatment following current clinical practice