Status:
COMPLETED
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis
Lead Sponsor:
Imperial College Healthcare NHS Trust
Conditions:
Glomerulonephritis, Membranous
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 r...
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 current...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00843856
Start Date
March 3 2009
End Date
September 18 2018
Last Update
December 12 2019
Active Locations (1)
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1
Hammersmith Hospital
London, United Kingdom, W12 OHS