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IgA NephropathyPhase 3STOP-IgANNCT00554502

Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy

A Phase 3 study testing supportive therapy with: ACE-inhibitor / ARB / Statin and supportive and immunosuppressive therapy in people with IgA Nephropathy, run by RWTH Aachen University at 34 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
IgA Nephropathy
What is being tested?
supportive therapy with: ACE-inhibitor / ARB / Statin and supportive and immunosuppressive therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
34 sitesGermany
Study dates
Feb 2008to Feb 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Germany34 sites

  • Medical Clinic II, University Hospital Aachen

    Aachen

  • 2. Medizinische Klinik, Nephrologie, Klinikum Augsburg

    Augsburg

  • Campus Charité Mitte, Medizinische Klinik - Schwerpunkt Nephrologie, Centrum 13

    Berlin

  • Charité Campus Virchow-Klinikum, Medizinische Klinik / Nephrologie

    Berlin

  • Helios-Klinikum Berlin-Buch, Nephrologie Charité CCB

    Berlin

  • St. Joseph Krankenhaus Medizinische Klinik II

    Berlin

  • Klinikum Bremen-Mitte, Medizinische Klinik III

    Bremen

  • Uniklinik Köln, Klinik IV für Innere Medizin, Nephrologie und Allgemeine Innere Medizin

    Cologne

  • Universitätsklinikum Dresden, Medizinische Klinik III, Bereich Nephrologie

    Dresden

  • Universitätsklinikum Düsseldorf, Klinik für Nephrologie

    Düsseldorf

  • Universitätsklinikum Erlangen, Medizinische Klinik IV

    Erlangen

  • Universitätsklinikum Essen, Klinik für Nieren- und Hochdruckkrankheiten

    Essen

  • Universitätsklinikum Freiburg, Innere Medizin IV

    Freiburg im Breisgau

  • Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II

    Giessen

  • Universitätsklinikum Göttingen, Zentrum Innere Medizin, Abteilung für Nephrologie und Rheumatologie

    Göttingen

  • Universitätsklinikum Hamburg-Eppendorf, 3. Medizinische Klinik und Poliklinik

    Hamburg

  • Medizinische Hochschule Hannover, Abteilung Nephrologie

    Hanover

  • Med. Universitätsklinik Heidelberg, Nierenzentrum Heidelberg, Sektion Nephrologie

    Heidelberg

  • Universitätsklinikum Jena, Medizinische Klinik III

    Jena

  • Westpfalz-Klinikum GmbH, Abteilung für Nephrologie und Transplantationsmedizin

    Kaiserslautern

  • Universitätsklinikum Magdeburg, Klinik für Nephrologie, Zentrum für Innere Medizin

    Magdeburg

  • Dialysezentrum am Brand

    Mainz

  • Universitätsklinikum Mannheim, V. Medizinische Klinik

    Mannheim

  • Universitätsklinikum Marburg, Klinik für Innere Medizin, Schwerpunkt Nephrologie

    Marburg

  • KfH Nierenzentrum

    München

  • Klinikum der LMU, Nephrologisches Zentrum

    München

  • Klinikum rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie

    München

  • Universitätsklinikum Münster, Medizinische Klinik und Poliklinik D

    Münster

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II

    Regensburg

  • Krankenhaus der Barmherzigen Brüder, Abteilung Innere Medizin II

    Trier

  • Universitätsklinikum Tübingen, Medizinische Klinik IV, Sektion für Nieren- und Hochdruckkrankheiten

    Tübingen

  • Dialyse-Zentrum Dres.med. PD H. Reichel, Th. Weinreich u. C.

    Villingen-Schwenningen

  • Zentrum für Nieren- und Hochdruckkrankheiten

    Wiesbaden

  • Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I

    Würzburg

Other trials in Germany

About this study

  • 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.
Read the 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).

Conditions
IgA Nephropathy
Being tested
supportive therapy with: ACE-inhibitor / ARB / Statin, supportive and immunosuppressive therapy
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • supportive therapy with: ACE-inhibitor / ARB / StatinDrug

    • 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.

  • supportive and immunosuppressive therapyDrug

    • 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
Study groups in NCT00554502
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: supportive therapy with: ACE-inhibitor / ARB / Statin
BActive comparatorNot described
Receives: Drug: supportive and immunosuppressive therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients reaching full clinical remission of their disease

    Measured: at the end of the 3 year study period.

  2. GFR loss of 15 ml/min or higher from baseline GFR

    Measured: at the end of the 3 year study period

Secondary outcomes (6)

  1. -Absolute GFR-change.

    Measured: at the end of the 3 years study period

  2. GFR loss >=30 ml/min from baseline GFR

    Measured: at the end of the 3 year study period

  3. -Onset of end stage renal disease.

    Measured: at the end of the 3 years study period

  4. Mean annual change in one over serum creatinine concentration

    Measured: at the end of the 3 years study period

  5. Proteinuria at 12 and 36 months

    Measured: 12 and 36 months

  6. Disappearance of microhematuria

    Measured: at the end of the 3 years study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00554502
Sponsor's protocol ID
STOP-IgAN
Acronym
STOP-IgAN
Status last verified
Sep 2015
First submitted
29 Oct 2007
Last updated
22 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.

    PubMed 38864363

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PubMed 38299639

  • 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.

    PubMed 26630142

  • 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.

    PubMed 26032537

  • 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.

    PubMed 18587715

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing supportive therapy with: ACE-inhibitor / ARB / Statin and supportive and immunosuppressive therapy in people with IgA Nephropathy, run by RWTH Aachen University at 34 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients reaching full clinical remission of their disease (time frame: at the end of the 3 year study period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00554502, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.

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