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

Academic Renal Unit
University of Bristol
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Study information

Study designMulti-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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) studiedProgressive membranous glomerulonephritis
InterventionRandomisation 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cyclosporin and prednisolone/chlorambucil
Primary outcome measureGlomerular filtration rate with a further decline of 20% being an end-point
Secondary outcome measuresProteinurea and adverse effects
Overall study start date15/01/1999
Completion date31/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120 (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 criteria1. Idiopathic membranous nephropathy with a 20% decline in glomerular filtration rate
2. Patients aged between 18 and 75
Key exclusion criteriaNot provided at time of registration
Date of first enrolment15/01/1999
Date of final enrolment31/03/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Renal Unit
Bristol
BS10 5NB
United Kingdom

Sponsor information

University of Bristol (UK)
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 logo "ROR" https://ror.org/0524sp257

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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