CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
tacrolimus +1 moredrug
Likely dose
Tacrolimus 2 mg twice daily, titrated to levels 5-12 ng/mL; mycophenolate mofetil 500 mg twice daily, titrated to levels 1.5-3 mg/L (in combination arm)AI-extracted
Key inclusion· 3
  • ✓Idiopathic membranous glomerulonephritis confirmed on renal biopsy
  • ✓Proteinuria with protein/creatinine ratio >100 units and hypoalbuminemia, OR >300 units with normal albumin, despite 3 months of maximum tolerated ACE inhibitors and/or angiotensin 2 antagonists (or shorter if life-threatening nephrotic complications)
  • ✓Age 18 to 80 years
Key exclusion· 4
  • ✕Hepatitis B, hepatitis C, or HIV positive
  • ✕Current or prior malignancy (all patients must have CT chest, abdomen, pelvis, and other investigations if clinically indicated)
  • ✕Untreated infection
  • ✕Any condition judged by the investigator that would be detrimental to the patient

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00843856
NCT00843856Phase 4Completed
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Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG)

Imperial College Healthcare NHS Trust·interventional·Posted Feb 13, 2009·Updated Dec 12, 2019

In Brief

A Phase 4 clinical trial evaluating tacrolimus and tacrolimus and mycophenolate mofetil for Glomerulonephritis, Membranous. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlomerulonephritis, Membranous
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2009
Enrollment StartMar 3, 2009
Primary CompletionMar 1, 2018
Study CompletionSep 18, 2018
TodayJul 2, 2026
Enrollment to primary: 9.0 yearsPosted 17.4 years ago

Interventions

tacrolimusdrug

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

tacrolimus and mycophenolate mofetildrug

tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L