Phase 4
Completed N=40
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis
Glomerulonephritis, Membranous
Source: ClinicalTrials.gov NCT00843856 ↗
Enrolled (actual)
40
Serious AEs
25.0%
Results posted
Dec 2019
Primary outcomePrimary: Number of Patient Who Gained Remission From the Nephrotic Syndrome — 8; 8 Participants — p=0.7
◆ Published Evidence
Established
39citations · ~6 / year
Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled 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.
Linked Publications (2)
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Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial.
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Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.