Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy (STOP-IgAN)
This study is ongoing, but not recruiting participants.
Sponsor:
RWTH Aachen University
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00554502
First received: October 29, 2007
Last updated: July 9, 2012
Last verified: July 2012
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Purpose
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
IgA Nephropathy |
Drug: supportive therapy with: ACE-inhibitor / ARB / Statin Drug: supportive and immunosuppressive therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy |
Further study details as provided by RWTH Aachen University:
Primary Outcome Measures:
- Patients reaching full clinical remission of their disease [ Time Frame: at the end of the 3 year study period. ]
- GFR loss of 15 ml/min or higher from baseline GFR [ Time Frame: at the end of the 3 year study period ]
Secondary Outcome Measures:
- -Absolute GFR-change. [ 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 ]
- -Onset of end stage renal disease. [ Time Frame: at the end of the 3 years study period ]
- 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 ]
- Disappearance of microhematuria [ Time Frame: at the end of the 3 years study period ]
| Estimated Enrollment: | 148 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: supportive therapy with: ACE-inhibitor / ARB / Statin
|
| Active Comparator: B |
Drug: supportive and immunosuppressive therapy
|
Detailed Description:
The best treatment of glomerular diseases of the kidney is currently not well defined. This study aims to answer if in patients with IgA nephropathy, the most common type of glomerulonephritis an immunosuppressive treatment (with the use of steroids and chemotherapy) added to a supportive treatment is more effective than a supportive treatment alone (with the use of drugs lowering the blood pressure and the urinary protein loss).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554502
Locations
| Germany | |
| Medical Clinic II, University Hospital Aachen | |
| Aachen, Germany | |
| 2. Medizinische Klinik, Nephrologie, Klinikum Augsburg | |
| Augsburg, Germany | |
| Campus Charité Mitte, Medizinische Klinik - Schwerpunkt Nephrologie, Centrum 13 | |
| Berlin, Germany | |
| St. Joseph Krankenhaus Medizinische Klinik II | |
| Berlin, Germany | |
| Charité Campus Virchow-Klinikum, Medizinische Klinik / Nephrologie | |
| Berlin, Germany | |
| Helios-Klinikum Berlin-Buch, Nephrologie Charité CCB | |
| Berlin, Germany | |
| Klinikum Bremen-Mitte, Medizinische Klinik III | |
| Bremen, Germany | |
| Universitätsklinikum Dresden, Medizinische Klinik III, Bereich Nephrologie | |
| Dresden, Germany | |
| Universitätsklinikum Düsseldorf, Klinik für Nephrologie | |
| Düsseldorf, Germany | |
| Universitätsklinikum Erlangen, Medizinische Klinik IV | |
| Erlangen, Germany | |
| Universitätsklinikum Essen, Klinik für Nieren- und Hochdruckkrankheiten | |
| Essen, Germany | |
| Universitätsklinikum Freiburg, Innere Medizin IV | |
| Freiburg, Germany | |
| Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II | |
| Gießen, Germany | |
| Universitätsklinikum Göttingen, Zentrum Innere Medizin, Abteilung für Nephrologie und Rheumatologie | |
| Göttingen, Germany | |
| Universitätsklinikum Hamburg-Eppendorf, 3. Medizinische Klinik und Poliklinik | |
| Hamburg, Germany | |
| Medizinische Hochschule Hannover, Abteilung Nephrologie | |
| Hannover, Germany | |
| Med. Universitätsklinik Heidelberg, Nierenzentrum Heidelberg, Sektion Nephrologie | |
| Heidelberg, Germany | |
| Universitätsklinikum Jena, Medizinische Klinik III | |
| Jena, Germany | |
| Westpfalz-Klinikum GmbH, Abteilung für Nephrologie und Transplantationsmedizin | |
| Kaiserslautern, Germany | |
| Uniklinik Köln, Klinik IV für Innere Medizin, Nephrologie und Allgemeine Innere Medizin | |
| Köln, Germany | |
| Universitätsklinikum Magdeburg, Klinik für Nephrologie, Zentrum für Innere Medizin | |
| Magdeburg, Germany | |
| Dialysezentrum am Brand | |
| Mainz, Germany | |
| Universitätsklinikum Mannheim, V. Medizinische Klinik | |
| Mannheim, Germany | |
| Universitätsklinikum Marburg, Klinik für Innere Medizin, Schwerpunkt Nephrologie | |
| Marburg, Germany | |
| Klinikum rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie | |
| München, Germany | |
| Klinikum der LMU, Nephrologisches Zentrum | |
| München, Germany | |
| KfH Nierenzentrum | |
| München, Germany | |
| Universitätsklinikum Münster, Medizinische Klinik und Poliklinik D | |
| Münster, Germany | |
| Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II | |
| Regensburg, Germany | |
| Krankenhaus der Barmherzigen Brüder, Abteilung Innere Medizin II | |
| Trier, Germany | |
| Universitätsklinikum Tübingen, Medizinische Klinik IV, Sektion für Nieren- und Hochdruckkrankheiten | |
| Tübingen, Germany | |
| Dialyse-Zentrum Dres.med. PD H. Reichel, Th. Weinreich u. C. | |
| Villingen-Schwenningen, Germany | |
| Zentrum für Nieren- und Hochdruckkrankheiten | |
| Wiesbaden, Germany | |
| Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I | |
| Würzburg, Germany | |
Sponsors and Collaborators
RWTH Aachen University
Investigators
| Principal Investigator: | Juergen Floege, Prof. Dr. | Medical Clinic II, University Hospital Aachen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Verena Deserno, Clinical Trials Centre Aachen |
| ClinicalTrials.gov Identifier: | NCT00554502 History of Changes |
| Other Study ID Numbers: | STOP-IgAN |
| Study First Received: | October 29, 2007 |
| Last Updated: | July 9, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Glomerulonephritis, IGA Kidney Diseases Glomerulonephritis Nephritis Urologic Diseases Autoimmune Diseases Immune System Diseases Angiotensin-Converting Enzyme Inhibitors |
Immunosuppressive Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013