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Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy (STOP-IgAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00554502
First received: October 29, 2007
Last updated: February 6, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A 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.
Active Comparator: B 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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
St. Joseph Krankenhaus Medizinische Klinik II
Berlin, Germany
Campus Charité Mitte, Medizinische Klinik - Schwerpunkt Nephrologie, Centrum 13
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
KfH Nierenzentrum
München, Germany
Klinikum der LMU, Nephrologisches Zentrum
München, Germany
Klinikum rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie
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: February 6, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Autoimmune Diseases
Glomerulonephritis
Immune System Diseases
Nephritis
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Immunosuppressive Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014