Glomerulonephritis, MembranousPhase 2/3NCT00135967
Mycophenolate Mofetil in Membranous Nephropathy
A Phase 2/3 study testing mycophenolate mofetil orally 1000 mg twice a day (BID), prednisone 0,5 mg/kg orally on alternate days and intravenous (i.v.) methylprednisolone 1000 mg, total 9 in people with Glomerulonephritis, Membranous, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects. 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?
- mycophenolate mofetil orally 1000 mg twice a day (BID), prednisone 0,5 mg/kg orally on alternate days and intravenous (i.v.) methylprednisolone 1000 mg, total 9
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2002to not given
- Phase
- Phase 2/3
- 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
- Membranous nephropathy
- Serum creatinine (Screat)> 1,5 mg/dl or ECC < 70 ml/min or increase Screat > 50%
- Proteinuria > 2 g/day
Who cannot join
- Systemic diseases
- Pregnancy wish
- Active infection
- Liver dysfunction
- Abnormal hematology lab
- Unstable angina
- Nonsteroidal anti-inflammatory agents (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 Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study
Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.
In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.
- Conditions
- Glomerulonephritis, Membranous
- Being tested
- mycophenolate mofetil orally 1000 mg twice a day (BID), prednisone 0,5 mg/kg orally on alternate days, intravenous (i.v.) methylprednisolone 1000 mg, total 9
- Keywords
- membranous nephropathy, mycophenolate mofetil, 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.
mycophenolate mofetil orally 1000 mg twice a day (BID)Drug
prednisone 0,5 mg/kg orally on alternate daysDrug
intravenous (i.v.) methylprednisolone 1000 mg, total 9Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function (serum creatinine)
proteinuria
Secondary outcomes (2)
side effects
relapse rate
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 startMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Jack F Wetzels, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135967
- Sponsor's protocol ID
- RUNMN02
- Status last verified
- Aug 2005
- First submitted
- 25 Aug 2005
- Last updated
- 6 Dec 2005
- Results posted
- No
Publications
Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56. doi: 10.1053/j.ajkd.2007.05.015.
PubMed 17660026
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study
- ClinicalTrials.gov ID
- NCT00135967
- Acronym / sponsor ID
- RUNMN02
- Conditions
- Glomerulonephritis, Membranous
- Keywords
- membranous nephropathy, mycophenolate mofetil, cyclophosphamide, prednisone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2002
- 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 and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.
In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Membranous nephropathy
- Serum creatinine (Screat)> 1,5 mg/dl or ECC < 70 ml/min or increase Screat > 50%
- Proteinuria > 2 g/day
Key exclusion criteria (7 listed)
- Systemic diseases
- Pregnancy wish
- Active infection
- Liver dysfunction
- Abnormal hematology lab
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 |
|---|---|---|
| mycophenolate mofetil orally 1000 mg twice a day (BID) | Drug | – |
| prednisone 0,5 mg/kg orally on alternate days | Drug | – |
| intravenous (i.v.) methylprednisolone 1000 mg, total 9 | Drug | – |
Primary outcome
renal function (serum creatinine)
proteinuria
2 secondary outcomes
side effects
relapse rate
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 6 Dec 2005.
- Derived from this study: PubMed 17660026Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56. doi: 10.1053/j.ajkd.2007.05.015.
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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 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 2/3 study testing mycophenolate mofetil orally 1000 mg twice a day (BID), prednisone 0,5 mg/kg orally on alternate days and intravenous (i.v.) methylprednisolone 1000 mg, total 9 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 7 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 6 Dec 2005. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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 NCT00135967, which also lists 1 linked publication.
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 6 Dec 2005; AzTrials last refreshed its copy on 26 Oct 2026.