Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy (STOP-IgAN)
This study is currently recruiting participants.
Verified by RWTH Aachen University, August 2008
Sponsored by: RWTH Aachen University
Information provided by: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00554502
  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 III

Drug Information available for: Cyclophosphamide Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Azathioprine Azathioprine sodium salt
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
A: Active Comparator Drug: supportive therapy with: ACE-inhibitor / ARB / Statin
  • Antihypertensive therapy with a target blood pressure below 125/75 mmHg (following current clinical guidelines).
  • ACE-inhibitors (ARB when an ACE-inhibitor is not tolerated)
  • Other antihypertensive medications depending on the clinical decision and following current guidelines.
  • Statin therapy
  • Dietary counseling for a low-sodium diet and, if GFR is below 60 ml/min, for a protein intake of 0.8 g/kg/day.
B: Active Comparator Drug: supportive and immunosuppressive therapy
  • supportive therapy as outlined above

  • depending on GFR:

    • methylprednisolone and prednisolone
    • cyclophosphamide and prednisolone; after 3 months azathioprine with prednisolone
  • Concomitant medication with the immunosuppressive treatment following current clinical practice

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 diagnosed within the last 3 years. Diagnosis has to be made by a neuropathologist.

  • Proteinuria of 0.75 g/day or higher 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554502

Contacts
Contact: Juergen Floege, Prof. Dr. 49-241-808-9530 STOP-IgAN@ukaachen.de

Locations
Germany
Medical Clinic II, University Hospital Aachen Recruiting
Aachen, Germany
Contact: Juergen Floege, Prof. Dr.     49-241-808-9530     STOP-IgAN@ukaachen.de    
2. Medizinische Klinik, Nephrologie, Klinikum Augsburg Recruiting
Augsburg, Germany
Contact: Horst Weihprecht, Dr. med.     49-821-400-2353        
Campus Charité Mitte, Medizinische Klinik - Schwerpunkt Nephrologie, Centrum 13 Recruiting
Berlin, Germany
Contact: Harm Peters, Prof. Dr.     49-30-450-514-072        
Helios-Klinikum Berlin-Buch, Nephrologie Charité CCB Recruiting
Berlin, Germany
Contact: Ralph Kettritz, Prof. Dr.     49-30-9401-52800-12800        
Charité Campus Virchow-Klinikum, Medizinische Klinik / Nephrologie Recruiting
Berlin, Germany
Contact: Ralf Schindler, Prof. Dr.     49-30-450-553-132        
Klinikum Bremen-Mitte, Medizinische Klinik III Recruiting
Bremen, Germany
Contact: Ekkehart Lison, Prof. Dr.     +49 421 4975347        
Universitätsklinikum Dresden, Medizinische Klinik III, Bereich Nephrologie Recruiting
Dresden, Germany
Contact: Peter Gross, Prof. Dr.     +49 351 458-4233        
Universitätsklinikum Düsseldorf, Klinik für Nephrologie Recruiting
Düsseldorf, Germany
Contact: Lars Christian Rump, Prof. Dr.     +49 211 81- 17 726        
Universitätsklinikum Erlangen, Medizinische Klinik IV Recruiting
Erlangen, Germany
Contact: Kai-Uwe Eckardt, Prof. Dr.     +49 911 398 2702        
Universitätsklinikum Essen, Klinik für Nieren- und Hochdruckkrankheiten Recruiting
Essen, Germany
Contact: Oliver Witzke, Prof. Dr.     +49 211-600 69299        
Universitätsklinikum Freiburg, Innere Medizin IV Recruiting
Freiburg, Germany
Contact: Hartmut Neumann, Prof. Dr.     +49 761 270 3363        
Universitätsklinikum Göttingen, Zentrum Innere Medizin, Abteilung für Nephrologie und Rheumatologie Recruiting
Göttingen, Germany
Contact: Gerhard Anton Müller     +49 551 396331        
Universitätsklinikum Hamburg-Eppendorf, 3. Medizinische Klinik und Poliklinik Recruiting
Hamburg, Germany
Contact: Rolf Stahl, Prof. Dr.     +49 40 42803 - 3908        
Medizinische Hochschule Hannover, Abteilung Nephrologie Recruiting
Hannover, Germany
Contact: Marion Haubitz, Prof. Dr.     +49 511 532 2429        
Med. Universitätsklinik Heidelberg, Nierenzentrum Heidelberg, Sektion Nephrologie Recruiting
Heidelberg, Germany
Contact: Martin Zeier, Prof. Dr.     +49 6221 9112-0        
Universitätsklinikum Jena, Medizinische Klinik III Recruiting
Jena, Germany
Contact: Gunter Wolf, Prof. Dr.     +49 3641 9324301        
Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II Recruiting
Gießen, Germany
Contact: Horst W. Birk, PD Dr.     49-641-994-2382        
Uniklinik Köln, Klinik IV für Innere Medizin, Nephrologie und Allgemeine Innere Medizin Recruiting
Köln, Germany
Contact: Manfred Pollok, Prof. Dr.     +49 221 478-4480        
Universitätsklinikum Magdeburg, Klinik für Nephrologie, Zentrum für Innere Medizin Recruiting
Magdeburg, Germany
Contact: Klaus H. Neumann, Prof. Dr.     +49 391 67 13236        
Universitätsklinikum Mannheim, V. Medizinische Klinik Recruiting
Mannheim, Germany
Contact: Peter Schnülle, Prof. Dr.     +49 621 383-2340        
Universitätsklinikum Marburg, Klinik für Innere Medizin, Schwerpunkt Nephrologie Recruiting
Marburg, Germany
Contact: Joachim Hoyer, Prof. Dr.     +49 6421 28 66481        
Klinikum der LMU, Nephrologisches Zentrum Recruiting
München, Germany
Contact: Michael Fischereder, Prof. Dr.     +49 89 5160 3325        
Klinikum rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie Recruiting
München, Germany
Contact: Jens Lutz, Prof. Dr.     +49 89 4140 2231        
KfH Nierenzentrum Recruiting
München, Germany
Contact: Johannes Mann, Prof. Dr.     +49 89 3 07 99 00        
Universitätsklinikum Münster, Medizinische Klinik und Poliklinik D Recruiting
Münster, Germany
Contact: Hermann Pavenstädt, Prof. Dr.     +49 251 83 47516        
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II Recruiting
Regensburg, Germany
Contact: Bernhard Krämer, Prof. Dr.     +49 941 944 7301        
Krankenhaus der Barmherzigen Brüder, Abteilung Innere Medizin II Recruiting
Trier, Germany
Contact: Stefan M. Weiner, Prof. Dr.     +49 651 208-2721        
Universitätsklinikum Tübingen, Medizinische Klinik IV, Sektion für Nieren- und Hochdruckkrankheiten Recruiting
Tübingen, Germany
Contact: Teut Risler, Prof. Dr.     49-7071-298-3172        
Dialyse-Zentrum Dres.med. PD H. Reichel, Th. Weinreich u. C. Recruiting
Villingen-Schwenningen, Germany
Contact: Arndt Petermann, Prof. Dr.     49-77-2039-080        
Zentrum für Nieren- und Hochdruckkrankheiten Recruiting
Wiesbaden, Germany
Contact: Bernd Krumme, Prof. Dr.     49-611-95683-0        
Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I Recruiting
Würzburg, Germany
Contact: Christoph Wanner, Prof. Dr.     49-931-2013-6331        
St. Joseph Krankenhaus Medizinische Klinik II Recruiting
Berlin, Germany
Contact: Christiane Erley, Prof. Dr.     49-30-7882-2379        
Westpfalz-Klinikum GmbH, Abteilung für Nephrologie und Transplantationsmedizin Recruiting
Kaiserslautern, Germany
Contact: Thomas Rath, Prof. Dr.     +49 631 203-1596        
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Juergen Floege, Prof. Dr. Medical Clinic II, University Hospital Aachen
  More Information

Study Homepage  This link exits the ClinicalTrials.gov site

Responsible Party: Clinical Trials Centre Aachen ( Prof. Dr. Ralf-Dieter Hilgers )
Study ID Numbers: STOP-IgAN
Study First Received: October 29, 2007
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00554502  
Health Authority: Germany: Ethics Commission

Study placed in the following topic categories:
Glomerulonephritis
Autoimmune Diseases
Methylprednisolone
Methylprednisolone acetate
Prednisolone acetate
Cyclophosphamide
Azathioprine
 Urologic Diseases
Nephritis
Prednisolone
Berger disease
Glomerulonephritis, IGA
Kidney Diseases
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services