Phase 4
N=40
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis
Glomerulonephritis, Membranous
Bottom Line
View on ClinicalTrials.gov: NCT00843856 ↗Enrolled (actual)
40
Serious AEs
25.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Patient Who Gained Remission From the Nephrotic Syndrome — 8; 8 Participants — p=0.7
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tacrolimus (Drug); tacrolimus and mycophenolate mofetil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patient Who Gained Remission From the Nephrotic Syndrome |
8; 8 | 0.7 |
| SECONDARY Number of Patients Achieved Remission |
16; 19 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00843856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.