Condition category
Urological and Genital Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
01/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Peter Mathieson

ORCID ID

Contact details

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

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

http://www.bris.ac.uk/

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

  1. 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.

Additional files

Editorial Notes