Immunosuppression for progressive membranous nephropathy
| ISRCTN | ISRCTN99959692 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99959692 |
| Protocol serial number | G9721265 |
| Sponsor | University of Bristol (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
Prof Peter Mathieson
Scientific
Scientific
Academic Renal Unit
University of Bristol
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclosporin and prednisolone/chlorambucil |
| Primary outcome measure(s) |
Glomerular filtration rate with a further decline of 20% being an end-point |
| Key secondary outcome measure(s) |
Proteinurea and adverse effects |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| 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
- United Kingdom
- England
Study participating centre
Academic Renal Unit
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
