Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9721265
Study information
Scientific title
Acronym
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
Ethics approval
Not provided at time of registration
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
Cyclosporin and prednisolone/chlorambucil
Primary outcome measures
Glomerular filtration rate with a further decline of 20% being an end-point
Secondary outcome measures
Proteinurea and adverse effects
Overall trial start date
15/01/1999
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Idiopathic membranous nephropathy with a 20% decline in glomerular filtration rate
2. Patients aged between 18 and 75
Participant type
Patient
Age group
Adult
Gender
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.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
15/01/1999
Recruitment end date
31/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Renal Unit
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 9000
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23312808
Publication citations
-
Results
Howman A, Chapman TL, Langdon MM, Ferguson C, Adu D, Feehally J, Gaskin GJ, Jayne DR, O'Donoghue D, Boulton-Jones M, Mathieson PW, Immunosuppression for progressive membranous nephropathy: a UK randomised controlled trial., Lancet, 2013, 381, 9868, 744-751, doi: 10.1016/S0140-6736(12)61566-9.