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Register:	EUCTR
Last refreshed on:	10 July 2015
Main ID:	EUCTR2007-000871-41-DE
Date of registration:	27/11/2007
Prospective Registration:	Yes
Primary sponsor:	RWTH Aachen
Public title:	Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN
Scientific title:	Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN
Date of first enrolment:	24/01/2008
Target sample size:	148
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000871-41
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Germany

Contacts

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Key inclusion & exclusion 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 <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).

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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-

Product Name: Cyclophosphamid
Pharmaceutical Form: Tablet
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50180
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Prednisolon
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50248
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-

Product Name: Methylprednisolon
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83432
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Product Name: supportive therapy
Pharmaceutical Form: Tablet

Primary Outcome(s)

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.

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.

Secondary Objective: Investigation of differences between the treatments regarding the number of patients loosing more than 15 ml/min of glomerular filtration rate (GFR).

Secondary Outcome(s)

Secondary ID(s)

STOPIgAN

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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