Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Immunosuppressive Agents

Criteria

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 neuropathologist.

• 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

1. arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or

2. impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min.

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 and women without sufficient contraception.

• 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).

• Significant liver dysfunction (more than three fold increased GPT compared to norm)

• Contraindication for immunosuppressive therapy, like

• acute or chronic infectious disease incl. hepatitis and HIV positive patients

• any malignancy

• leukocytopenia, thrombocytopenia or known allergy against prednisolone, cyclophosphamide or azathioprine

• active intestinal bleeding, active gastric or duodenal ulcer

• Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases)

• 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).

• Alcohol or drug abuse

• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

• Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

• Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months.

• Subjects who are in any state of dependency to the sponsor or the investigators.

• Employees of the sponsor or the investigators.

• Subjects who have been committed to an institution by legal or regulatory order.