Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy - Full Text View

Sponsor:	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

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 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

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

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
St. Joseph Krankenhaus Medizinische Klinik II	Recruiting
Berlin, Germany
Contact: Christiane Erley, Prof. Dr. 49-30-7882-2379
Charité Campus Virchow-Klinikum, Medizinische Klinik / Nephrologie	Recruiting
Berlin, Germany
Contact: Ralf Schindler, Prof. Dr. 49-30-450-553-132
Helios-Klinikum Berlin-Buch, Nephrologie Charité CCB	Recruiting
Berlin, Germany
Contact: Ralph Kettritz, Prof. Dr. 49-30-9401-52800-12800
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 Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II	Recruiting
Gießen, Germany
Contact: Horst W. Birk, PD Dr. 49-641-994-2382
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
Westpfalz-Klinikum GmbH, Abteilung für Nephrologie und Transplantationsmedizin	Recruiting
Kaiserslautern, Germany
Contact: Thomas Rath, Prof. Dr. +49 631 203-1596
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
Dialysezentrum am Brand	Recruiting
Mainz, Germany
Contact: Stefan Westpfalen, Dr. 06131280660
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 rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie	Recruiting
München, Germany
Contact: Jens Lutz, Prof. Dr. +49 89 4140 2231
Klinikum der LMU, Nephrologisches Zentrum	Recruiting
München, Germany
Contact: Michael Fischereder, Prof. Dr. +49 89 5160 3325
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 Banas, 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

Sponsors and Collaborators

RWTH Aachen University

Investigators

Principal Investigator:

Juergen Floege, Prof. Dr.

Medical Clinic II, University Hospital Aachen

More Information

Additional Information:

Study Homepage This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Prof. Dr. Ralf-Dieter Hilgers, 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:	September 25, 2009
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 February 09, 2012