Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 6 October 2015
• Main ID: NCT00554502
• Date of registration: 29/10/2007
• Prospective Registration: Yes
• Primary sponsor: RWTH Aachen University
• 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
• Date of first enrolment: February 2008
• Target sample size: 148
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00554502
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Juergen Floege, Prof. Dr.
• Affiliation: Medical Clinic II, University Hospital Aachen

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
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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: supportive therapy with: ACE-inhibitor / ARB / Statin

Drug: supportive and immunosuppressive therapy

Primary Outcome(s)

GFR loss of 15 ml/min or higher from baseline GFR [Time Frame: at the end of the 3 year study period]

Patients reaching full clinical remission of their disease [Time Frame: at the end of the 3 year study period.]

Secondary Outcome(s)

Mean annual change in one over serum creatinine concentration [Time Frame: at the end of the 3 years study period]

Proteinuria at 12 and 36 months [Time Frame: 12 and 36 months]

-Absolute GFR-change. [Time Frame: at the end of the 3 years study period]

Disappearance of microhematuria [Time Frame: at the end of the 3 years study period]

-Onset of end stage renal disease. [Time Frame: at the end of the 3 years study period]

GFR loss >=30 ml/min from baseline GFR [Time Frame: at the end of the 3 year study period]

Secondary ID(s)

STOP-IgAN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors