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Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG) (MTAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843856
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : April 10, 2019
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, Membranous Drug: tacrolimus Drug: tacrolimus and mycophenolate mofetil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis
Study Start Date : February 2009
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: tacrolimus
Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L
Drug: tacrolimus
tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml
Other Name: prograff

Active Comparator: tacrolimus and mycophenolate mofetil
tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L
Drug: tacrolimus and mycophenolate mofetil
tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Other Names:
  • prograf
  • cellcept

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843856

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United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 OHS
Sponsors and Collaborators
Imperial College Healthcare NHS Trust

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Responsible Party: Imperial College Healthcare NHS Trust Identifier: NCT00843856     History of Changes
Other Study ID Numbers: 2008-001009-41
EUDRACT Number 2008-001009-41
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Glomerulonephritis, Membranous
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents