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

Glomerulonephritis, Membranous Clinical Trial

— MTAC  

Official title:

Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843856
• Other study ID #: 13HH1282
• Secondary ID: 2008-001009-41
• Status: Completed
• Phase: Phase 4
• Start date: March 3, 2009
• Est. completion date: September 18, 2018

Study information

• Verified date: November 2019
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 18, 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, Membranous

Intervention

Drug:
• tacrolimus
tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml
• 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

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 glomer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patient Who Gained Remission From the Nephrotic Syndrome	Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.	10-109 weeks
Secondary	Number of Patients Achieved Remission	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.	6-12 months