Glomerulonephritis, MembranousPhase 3NCT00135954
Treatment of Patients With Idiopathic Membranous Nephropathy
A Phase 3 study testing Cyclophosphamide and steroids in people with Glomerulonephritis, Membranous, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glomerulonephritis, Membranous
- What is being tested?
- Cyclophosphamide and steroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 1997to Jul 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic membranous nephropathy
- Serum creatinine < 1.5 mg/dl
- Nephrotic syndrome
Who cannot join
- Infection
- Instable angina
- Systemic disease
- Pregnancy
- Renal vein thrombosis
- Prior therapy with immunosuppressant agents
- Liver dysfunction
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Nephrology Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.
Read the detailed description
Inclusion Criteria:
- patients with idiopathic membranous nephropathy
- nephrotic syndrome
- normal renal function (serum creatinine [Screat] < 1.5 mg/dl)
- elevated urinary beta2-microglobulin and IgG
Immunosuppressive therapy consisting of:
- cyclophosphamide 1.5 mg/kg/day for 12 months
- prednisone orally, 0.5 mg/kg on alternate days for 6 months
- i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122
Study Groups:
- early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk
- late: start of therapy after deterioration of renal function (increase of Screat > 25% and Screat > 1.5 mg/dl)
Main Outcome Parameters:
- serum creatinine
- remission of proteinuria
- period of nephrotic proteinuria
- major side effects: hospitalisations, infections
- Conditions
- Glomerulonephritis, Membranous
- Being tested
- Cyclophosphamide and steroids
- Keywords
- membranous nephropathy, cyclophosphamide, prednisone
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide and steroidsDrug
Also called prednisolone, endoxan
comparison of difference in time of start of therapy
| Study group | Role | What they receive |
|---|---|---|
| late intervention | Other | cyclophosphamide and steroids started at time of renal insufficiency Receives: Drug: Cyclophosphamide and steroids |
| early intervention | Experimental | immediate start of cyclophosphamide and steroids Receives: Drug: Cyclophosphamide and steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function (serum creatinine)
proteinuria
side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startJul 1997
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack F Wetzels, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135954
- Sponsor's protocol ID
- RUNMN01
- Status last verified
- Feb 2007
- First submitted
- 25 Aug 2005
- Last updated
- 28 Jan 2014
- Results posted
- No
Publications
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
PubMed 34778952Hofstra JM, Branten AJ, Wirtz JJ, Noordzij TC, du Buf-Vereijken PW, Wetzels JF. Early versus late start of immunosuppressive therapy in idiopathic membranous nephropathy: a randomized controlled trial. Nephrol Dial Transplant. 2010 Jan;25(1):129-36. doi: 10.1093/ndt/gfp390. Epub 2009 Aug 8.
PubMed 19666912
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT00135954
- Acronym / sponsor ID
- RUNMN01
- Conditions
- Glomerulonephritis, Membranous
- Keywords
- membranous nephropathy, cyclophosphamide, prednisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 1997
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.
Detailed description
Inclusion Criteria:
- patients with idiopathic membranous nephropathy
- nephrotic syndrome
- normal renal function (serum creatinine [Screat] < 1.5 mg/dl)
- elevated urinary beta2-microglobulin and IgG
Immunosuppressive therapy consisting of:
- cyclophosphamide 1.5 mg/kg/day for 12 months
- prednisone orally, 0.5 mg/kg on alternate days for 6 months
- i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122
Study Groups:
- early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk
- late: start of therapy after deterioration of renal function (increase of Screat > 25% and Screat > 1.5 mg/dl)
Main Outcome Parameters:
- serum creatinine
- remission of proteinuria
- period of nephrotic proteinuria
- major side effects: hospitalisations, infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| late intervention | Other | Drug: Cyclophosphamide and steroidscyclophosphamide and steroids started at time of renal insufficiency |
| early intervention | Experimental | Drug: Cyclophosphamide and steroidsimmediate start of cyclophosphamide and steroids |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic membranous nephropathy
- Serum creatinine < 1.5 mg/dl
- Nephrotic syndrome
Key exclusion criteria (8 listed)
- Infection
- Instable angina
- Systemic disease
- Pregnancy
- Renal vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide and steroidsAlso: prednisolone, endoxancomparison of difference in time of start of therapy | Drug | early intervention, late intervention |
Primary outcome
renal function (serum creatinine)
proteinuria
side effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Derived from this study: PubMed 34778952von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
- Derived from this study: PubMed 19666912Hofstra JM, Branten AJ, Wirtz JJ, Noordzij TC, du Buf-Vereijken PW, Wetzels JF. Early versus late start of immunosuppressive therapy in idiopathic membranous nephropathy: a randomized controlled trial. Nephrol Dial Transplant. 2010 Jan;25(1):129-36. doi: 10.1093/ndt/gfp390. Epub 2009 Aug 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack F Wetzels, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide and steroids in people with Glomerulonephritis, Membranous, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 8 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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
renal function (serum creatinine). The study lists 3 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 NCT00135954, which also lists 2 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 28 Jan 2014.