NCT00554502

Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The best treatment of glomerular diseases of the kidney is currently not well defined. This study aims to answer if in patients with IgA nephropathy, the most common type of glomerulonephritis an immunosuppressive treatment (with the use of steroids and chemotherapy) added to a supportive treatment is more effective than a supportive treatment alone (with the use of drugs lowering the blood pressure and the urinary protein loss).

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2007-11-07
• Last updated: 2015-09-22

Locations

34 sites across 1 country: Germany