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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000871-41-DE

Enrollment

148

Registered

2007-11-27

Start date

2008-01-24

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA nephropathy (IgAN) as the most common type of glomerulonephritis. MedDRA version: 16.1 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Azathioprine Pharmaceutical Form: Tablet INN or Proposed INN: AZATHIOPRINE CAS Number: 446-86-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- P

Eligibility

Sex/Gender

All

Inclusion 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 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 IgA nephropathy.;Secondary Objective: Investigation of differences between the treatments regarding the number of patients loosing more than 15 ml/min of glomerular filtration rate (GFR).;Primary end point(s): -Patients in full clinical remission of their disease. Full clinical remission is defined as proteinuria < 0.2 g/g and stable renal function (GFR loss of < 5 ml/min from baseline GFR at the end of the 3 year study period). -GFR loss of 15 ml/min or higher from baseline GFR at the end of the 3 year study period.	—

Measure

Time frame

Main Objective: 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 IgA nephropathy.;Secondary Objective: Investigation of differences between the treatments regarding the number of patients loosing more than 15 ml/min of glomerular filtration rate (GFR).;Primary end point(s): -Patients in full clinical remission of their disease. Full clinical remission is defined as proteinuria < 0.2 g/g and stable renal function (GFR loss of < 5 ml/min from baseline GFR at the end of the 3 year study period). -GFR loss of 15 ml/min or higher from baseline GFR at the end of the 3 year study period.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026