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Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy

NCT00554502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2015-09-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

supportive therapy with: ACE-inhibitor / ARB / Statin

* 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.

DRUG

supportive and immunosuppressive therapy

* 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

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Juergen Floege, Prof. Dr. · Medical Clinic II, University Hospital Aachen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554502 on ClinicalTrials.gov