|
ISRCTN
|
ISRCTN99959692
|
|
DOI
|
10.1186/ISRCTN99959692
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Immunosuppression for progressive membranous nephropathy
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
G9721265
|
|
Study hypothesis
|
To test whether immunosuppression alters the natural history of progressive membranous glomerulonephritis and to compare two types of immunosuppressive treatment: cyclosporin and prednisolone/chlorambucil
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Multi-centre randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Progressive membranous glomerulonephritis
|
|
Participants - inclusion criteria
|
1. Idiopathic membranous nephropathy with a 20% decline in glomerular filtration rate
2. Patients aged between 18 and 75
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
15/01/1999
|
|
Anticipated end date
|
31/03/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
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.
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Glomerular filtration rate with a further decline of 20% being an end-point
|
|
Secondary outcome measure(s)
|
Proteinurea and adverse effects
|
|
Sources of funding
|
Medical Research Council (MRC) (UK)
|
|
Trial website
|
|
|
Publications
|
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23312808
|
|
Contact name
|
Professor
Peter
Mathieson
|
|
Address
|
Academic Renal Unit
University of Bristol
Southmead Hospital
Westbury-on-Trym
|
|
City/town
|
Bristol
|
|
Zip/Postcode
|
BS10 5NB
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
University of Bristol (UK)
|
|
Address
|
Senate House
Tyndall Avenue
|
|
City/town
|
Bristol
|
|
Zip/Postcode
|
BS8 1TH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)117 928 9000
|
|
Email
|
|
|
Sponsor website:
|
http://www.bris.ac.uk/
|
|
Date applied
|
25/10/2000
|
|
Last edited
|
01/02/2013
|
|
Date ISRCTN assigned
|
25/10/2000
|
