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

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
supportive therapy with: ACE-inhibitor / ARB / Statin
supportive and immunosuppressive therapy
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Clinic II, University Hospital Aachen
  • 2. Medizinische Klinik, Nephrologie, Klinikum Augsburg
  • Campus Charité Mitte, Medizinische Klinik - Schwerpunkt Nephrologie, Centrum 13
  • Charité Campus Virchow-Klinikum, Medizinische Klinik / Nephrologie
  • Helios-Klinikum Berlin-Buch, Nephrologie Charité CCB
  • St. Joseph Krankenhaus Medizinische Klinik II
  • Klinikum Bremen-Mitte, Medizinische Klinik III
  • Universitätsklinikum Dresden, Medizinische Klinik III, Bereich Nephrologie
  • Universitätsklinikum Düsseldorf, Klinik für Nephrologie
  • Universitätsklinikum Erlangen, Medizinische Klinik IV
  • Universitätsklinikum Essen, Klinik für Nieren- und Hochdruckkrankheiten
  • Universitätsklinikum Freiburg, Innere Medizin IV
  • Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II
  • Universitätsklinikum Göttingen, Zentrum Innere Medizin, Abteilung für Nephrologie und Rheumatologie
  • Universitätsklinikum Hamburg-Eppendorf, 3. Medizinische Klinik und Poliklinik
  • Medizinische Hochschule Hannover, Abteilung Nephrologie
  • Med. Universitätsklinik Heidelberg, Nierenzentrum Heidelberg, Sektion Nephrologie
  • Universitätsklinikum Jena, Medizinische Klinik III
  • Westpfalz-Klinikum GmbH, Abteilung für Nephrologie und Transplantationsmedizin
  • Uniklinik Köln, Klinik IV für Innere Medizin, Nephrologie und Allgemeine Innere Medizin
  • Universitätsklinikum Magdeburg, Klinik für Nephrologie, Zentrum für Innere Medizin
  • Dialysezentrum am Brand
  • Universitätsklinikum Mannheim, V. Medizinische Klinik
  • Universitätsklinikum Marburg, Klinik für Innere Medizin, Schwerpunkt Nephrologie
  • KfH Nierenzentrum
  • Klinikum der LMU, Nephrologisches Zentrum
  • Klinikum rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie
  • Universitätsklinikum Münster, Medizinische Klinik und Poliklinik D
  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II
  • Krankenhaus der Barmherzigen Brüder, Abteilung Innere Medizin II
  • Universitätsklinikum Tübingen, Medizinische Klinik IV, Sektion für Nieren- und Hochdruckkrankheiten
  • Dialyse-Zentrum Dres.med. PD H. Reichel, Th. Weinreich u. C.
  • Zentrum für Nieren- und Hochdruckkrankheiten
  • Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Patients reaching full clinical remission of their disease
GFR loss of 15 ml/min or higher from baseline GFR

Secondary Outcome Measures

-Absolute GFR-change.
GFR loss >=30 ml/min from baseline GFR
-Onset of end stage renal disease.
Mean annual change in one over serum creatinine concentration
Proteinuria at 12 and 36 months
Disappearance of microhematuria

Full Information

First Posted
October 29, 2007
Last Updated
September 21, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT00554502
Brief Title
Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy
Acronym
STOP-IgAN
Official Title
Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
supportive therapy with: ACE-inhibitor / ARB / Statin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
supportive and immunosuppressive therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Patients reaching full clinical remission of their disease
Time Frame
at the end of the 3 year study period.
Title
GFR loss of 15 ml/min or higher from baseline GFR
Time Frame
at the end of the 3 year study period
Secondary Outcome Measure Information:
Title
-Absolute GFR-change.
Time Frame
at the end of the 3 years study period
Title
GFR loss >=30 ml/min from baseline GFR
Time Frame
at the end of the 3 year study period
Title
-Onset of end stage renal disease.
Time Frame
at the end of the 3 years study period
Title
Mean annual change in one over serum creatinine concentration
Time Frame
at the end of the 3 years study period
Title
Proteinuria at 12 and 36 months
Time Frame
12 and 36 months
Title
Disappearance of microhematuria
Time Frame
at the end of the 3 years study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Floege, Prof. Dr.
Organizational Affiliation
Medical Clinic II, University Hospital Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Clinic II, University Hospital Aachen
City
Aachen
Country
Germany
Facility Name
2. Medizinische Klinik, Nephrologie, Klinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Campus Charité Mitte, Medizinische Klinik - Schwerpunkt Nephrologie, Centrum 13
City
Berlin
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum, Medizinische Klinik / Nephrologie
City
Berlin
Country
Germany
Facility Name
Helios-Klinikum Berlin-Buch, Nephrologie Charité CCB
City
Berlin
Country
Germany
Facility Name
St. Joseph Krankenhaus Medizinische Klinik II
City
Berlin
Country
Germany
Facility Name
Klinikum Bremen-Mitte, Medizinische Klinik III
City
Bremen
Country
Germany
Facility Name
Universitätsklinikum Dresden, Medizinische Klinik III, Bereich Nephrologie
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf, Klinik für Nephrologie
City
Düsseldorf
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Medizinische Klinik IV
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum Essen, Klinik für Nieren- und Hochdruckkrankheiten
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Innere Medizin IV
City
Freiburg
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II
City
Gießen
Country
Germany
Facility Name
Universitätsklinikum Göttingen, Zentrum Innere Medizin, Abteilung für Nephrologie und Rheumatologie
City
Göttingen
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf, 3. Medizinische Klinik und Poliklinik
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Abteilung Nephrologie
City
Hannover
Country
Germany
Facility Name
Med. Universitätsklinik Heidelberg, Nierenzentrum Heidelberg, Sektion Nephrologie
City
Heidelberg
Country
Germany
Facility Name
Universitätsklinikum Jena, Medizinische Klinik III
City
Jena
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH, Abteilung für Nephrologie und Transplantationsmedizin
City
Kaiserslautern
Country
Germany
Facility Name
Uniklinik Köln, Klinik IV für Innere Medizin, Nephrologie und Allgemeine Innere Medizin
City
Köln
Country
Germany
Facility Name
Universitätsklinikum Magdeburg, Klinik für Nephrologie, Zentrum für Innere Medizin
City
Magdeburg
Country
Germany
Facility Name
Dialysezentrum am Brand
City
Mainz
Country
Germany
Facility Name
Universitätsklinikum Mannheim, V. Medizinische Klinik
City
Mannheim
Country
Germany
Facility Name
Universitätsklinikum Marburg, Klinik für Innere Medizin, Schwerpunkt Nephrologie
City
Marburg
Country
Germany
Facility Name
KfH Nierenzentrum
City
München
Country
Germany
Facility Name
Klinikum der LMU, Nephrologisches Zentrum
City
München
Country
Germany
Facility Name
Klinikum rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie
City
München
Country
Germany
Facility Name
Universitätsklinikum Münster, Medizinische Klinik und Poliklinik D
City
Münster
Country
Germany
Facility Name
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II
City
Regensburg
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder, Abteilung Innere Medizin II
City
Trier
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Medizinische Klinik IV, Sektion für Nieren- und Hochdruckkrankheiten
City
Tübingen
Country
Germany
Facility Name
Dialyse-Zentrum Dres.med. PD H. Reichel, Th. Weinreich u. C.
City
Villingen-Schwenningen
Country
Germany
Facility Name
Zentrum für Nieren- und Hochdruckkrankheiten
City
Wiesbaden
Country
Germany
Facility Name
Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
City
Würzburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26630142
Citation
Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463.
Results Reference
derived
PubMed Identifier
26032537
Citation
Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
Results Reference
derived
PubMed Identifier
18587715
Citation
Eitner F, Ackermann D, Hilgers RD, Floege J. Supportive Versus Immunosuppressive Therapy of Progressive IgA nephropathy (STOP) IgAN trial: rationale and study protocol. J Nephrol. 2008 May-Jun;21(3):284-9.
Results Reference
derived

Learn more about this trial

Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy

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