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

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ClinicalTrials.gov Identifier: NCT00843856

Recruitment Status : Completed

First Posted : February 13, 2009

Results First Posted : December 12, 2019

Last Update Posted : December 12, 2019

Sponsor:

Information provided by (Responsible Party):

Imperial College Healthcare NHS Trust

Study Description

Brief Summary:

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

Detailed Description:

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 Design

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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 (IMG)
Actual Study Start Date :	March 3, 2009
Actual Primary Completion Date :	March 2018
Actual Study Completion Date :	September 18, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Mycophenolic acid Mycophenolate sodium Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil

Genetic and Rare Diseases Information Center resources: Glomerulonephritis Membranous Nephropathy

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Number of Patient Who Gained Remission From the Nephrotic Syndrome [ Time Frame: 10-109 weeks ]
Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.

Secondary Outcome Measures :

Number of Patients Achieved Remission [ Time Frame: 6-12 months ]
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.

Eligibility Criteria

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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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00843856

Locations

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United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 OHS

Sponsors and Collaborators

Imperial College Healthcare NHS Trust

Investigators

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Principal Investigator:	Megan Griffith, MBChB PhD	Imperial College London

Study Documents (Full-Text)

Documents provided by Imperial College Healthcare NHS Trust:

Study Protocol and Statistical Analysis Plan [PDF] June 1, 2008

More Information

Publications of Results:

Nikolopoulou A, Condon M, Turner-Stokes T, Cook HT, Duncan N, Galliford JW, Levy JB, Lightstone L, Pusey CD, Roufosse C, Cairns TD, Griffith ME. Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial. BMC Nephrol. 2019 Sep 6;20(1):352. doi: 10.1186/s12882-019-1539-z.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11:CD004293. doi: 10.1002/14651858.CD004293.pub4. Review.

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Responsible Party:	Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:	NCT00843856
Other Study ID Numbers:	13HH1282 2008-001009-41 ( EudraCT Number )
First Posted:	February 13, 2009 Key Record Dates
Results First Posted:	December 12, 2019
Last Update Posted:	December 12, 2019
Last Verified:	November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Imperial College Healthcare NHS Trust:


Glomerulonephritis

Additional relevant MeSH terms:

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Glomerulonephritis Glomerulonephritis, Membranous Nephritis Kidney Diseases Urologic Diseases Autoimmune Diseases Immune System Diseases Mycophenolic Acid Tacrolimus 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

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