Overview

This trial is active, not recruiting.

Condition nephrotic syndrome secondary to idiopathic membranous glomerulonephritis
Treatments tacrolimus, tacrolimus and mycophenolate mofetil
Phase phase 4
Sponsor Imperial College Healthcare NHS Trust
Start date February 2009
End date February 2017
Trial size 40 participants
Trial identifier NCT00843856, 2008-001009-41, EUDRACT Number 2008-001009-41

Summary

Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to treat and if persistent leads to end stage renal failure in a significant number of patients. It is currently treated in this institution with tacrolimus monotherapy. This is effective in the majority of patients in reducing proteinuria but the remissions are often partial and patients tend to relapse when the tacrolimus treatment is stopped. We propose to use mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy and less progression of renal failure. This will be a randomised control trial, patients will be randomised to receive treatment with tacrolimus alone (our current standard therapy)or treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for up to 2 years and then be monitored for relapse of their nephrotic syndrome.

Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of membranous glomerulonephritis it is likely to improve the initial response to treatment and reduce the risk of relapse on stopping therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L
tacrolimus prograff
tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml
(Active Comparator)
tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L
tacrolimus and mycophenolate mofetil prograf
tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L

Primary Outcomes

Measure
Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy. This will be initially measured at 6 months post withdrawal of tacrolimus therapy.
time frame: 6 months post withdrawl or tacrolimus therapy

Secondary Outcomes

Measure
The time to obtaining remission from proteinuria The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate
time frame: 6-12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Idiopathic membranous glomerulonephritis on renal biopsy - 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 (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression) - Male or female patients aged 18 to 80 years Exclusion Criteria: - Hepatitis B hepatitis C or HIV positive - Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated) - Untreated infection - Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception - Any condition judged by the investigator that would cause the study to be detrimental to the patient

Additional Information

Official title Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Imperial College Healthcare NHS Trust.