Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgA

• Conditions: IgA nephropathy (IgAN) as the most common type of glomerulonephritis.; MedDRA version: 16.1Level: PTClassification code 10021263Term: IgA nephropathySystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2007-000871-41-DE
• Lead Sponsor: RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

- Male or female patients from 18-70 years with histologically proven primary IgAN with typical mesangioproliferative features. Diagnosis has to be made by a nephropathologist. - Proteinuria above 0.75 g/day within 12 weeks prior to or at the first visit in the run-in phase (month -6) and presence of at least one further risk factor for the development of end stage renal disease a) arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or b) impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known allergy or intolerance to study medication (except in case of ACE-inhibitor, in which case a change to an angiotensin receptor blocker is possible). - Women who are pregnant or breastfeeding. - Women without sufficient contraception. - Contraindication for immunosuppressive therapy - Any prior immunosuppressive therapy. - Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits). - Secondary IgAN or diseases associated with glomerular deposits of IgA. - Additional other chronic renal disease. - Creatinine clearance below 30 ml/min (mean of 3 measurements).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified