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

• Status: Completed
• Trial end date: 2018-09-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College Healthcare NHS Trust
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

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