Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG)
This trial is active, not recruiting.
|Condition||nephrotic syndrome secondary to idiopathic membranous glomerulonephritis|
|Treatments||tacrolimus, tacrolimus and mycophenolate mofetil|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
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
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
|Official title||Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis|
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