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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Imperial College Healthcare NHS Trust
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT00843856
First received: February 12, 2009
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Nephrotic Syndrome Secondary to Idiopathic Membranous Glomerulonephritis
Drug: tacrolimus
Drug: tacrolimus and mycophenolate mofetil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis

Resource links provided by NLM:


Further study details as provided by Imperial College Healthcare NHS Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843856

Locations
United Kingdom
Hammersmith Hospital Recruiting
London, United Kingdom, W12 OHS
Contact: Megan E Griffith, MBChB (hons)PhD    02083835272    megan.griffith@imperial.nhs.uk   
Contact: Tom D Cairns    02083835272    tom.cairns@nhs.net   
Principal Investigator: Dr M Griffith, MBChB PhD         
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
  More Information

No publications provided

Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT00843856     History of Changes
Other Study ID Numbers: 2008-001009-41, EUDRACT Number 2008-001009-41
Study First Received: February 12, 2009
Last Updated: September 26, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, Membranous
Nephrotic Syndrome
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Nephritis
Nephrosis
Urologic Diseases
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014