mycophenylate mofetil and tacrolimus vs tacrolimus alone for the treatment of nephrotic syndrome secondary to idiopathic membranous glomerulonephritis - MTAC

Phase 1

• Conditions: Idiopathic Membranous Glomerulonephritis; MedDRA version: 9.1 Level: LLT Classification code 10029167 Term: Nephrotic syndrome with lesion of membranous glomerulonephritis

• Registration Number: EUCTR2008-001009-41-GB
• Lead Sponsor: Imperial College Healthcare NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-09
• Study Completion: 2018-09-19
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Idiopathic membranous glomerulonephritis on renal biopsy
Heavy proteinuria- protein/creatinine ratio (PCR) >100 units with hypoalbuminaemia, or PCR >300 units with normal serum albumin -despite 3 months treatment with maximum tolerated doses of ACE inhibitors and angiotensin 2 antagonists.
Male or female patients age 18-80 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hepatits B, hepatitis C or HIV positive
Malignancy
Untreated infection
Females who are pregnant, or breastfeeding, or at risk of pregnancy and not using adequate contraception.
Any condition judged by the investigator that would cause the study to be detrimental to the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus prevents relapse of nephrotic syndrome in patients with idiopathic membranous glomerulonephritis;Secondary Objective: To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus is more effective at decreasing proteinuria and maintaining renal function.;Primary end point(s): Prevention of relapse of proteinuria on withdrawal of tacrolimus therapy, (all patients followed for at least 6 months post cessation of tacrolimus).