Immunosuppression for progressive membranous nephropathy
| ISRCTN | ISRCTN99959692 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99959692 |
| Secondary identifying numbers | G9721265 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 01/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Professor Peter Mathieson
Scientific
Scientific
Academic Renal Unit
University of Bristol
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To test whether immunosuppression alters the natural history of progressive membranous glomerulonephritis and to compare two types of immunosuppressive treatment: cyclosporin and prednisolone/chlorambucil |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Progressive membranous glomerulonephritis |
| Intervention | Randomisation will be between three groups: 1. One receiving supportive treatment only 2. One receiving 12 months treatment with cyclosporin 3. One receiving six months treatment with a combination of prednisolone and chlorambucil |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclosporin and prednisolone/chlorambucil |
| Primary outcome measure | Glomerular filtration rate with a further decline of 20% being an end-point |
| Secondary outcome measures | Proteinurea and adverse effects |
| Overall study start date | 15/01/1999 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 (40 in each group), interim follow-up at 2 years, final follow-up at 5 years. Added 23/09/09: Closed to recruitment, 108 recruited, in follow-up. |
| Key inclusion criteria | 1. Idiopathic membranous nephropathy with a 20% decline in glomerular filtration rate 2. Patients aged between 18 and 75 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/01/1999 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Renal Unit
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
University of Bristol (UK)
University/education
University/education
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Phone | +44 (0)117 928 9000 |
|---|---|
| Website | http://www.bris.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/03/2013 | Yes | No |
