mycophenylate mofetil and tacrolimus vs tacrolimus alone for the treatment of nephrotic syndrome secondary to idiopathic membranous glomerulonephritis - MTAC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001009-41-GB

Enrollment

Registered

2008-05-09

Start date

2008-10-08

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Membranous Glomerulonephritis MedDRA version: 9.1 Level: LLT Classification code 10029167 Term: Nephrotic syndrome with lesion of membranous glomerulonephritis

Interventions

Trade Name: Mycophenylate mofetil only one brand available -cellcept Product Name: mycopheylate mofetil Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Idiopathic membranous glomerulonephritis on renal biopsy Heavy 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. Male or female patients age 18-80 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hepatits B, hepatitis C or HIV positive Malignancy Untreated infection Females who are pregnant, or breastfeeding, or at risk of pregnancy and not using adequate contraception. Any condition judged by the investigator that would cause the study to be detrimental to the patient.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus prevents relapse of nephrotic syndrome in patients with idiopathic membranous glomerulonephritis;Secondary Objective: To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus is more effective at decreasing proteinuria and maintaining renal function.;Primary end point(s): Prevention of relapse of proteinuria on withdrawal of tacrolimus therapy, (all patients followed for at least 6 months post cessation of tacrolimus).	—

Measure

Time frame

Main Objective: To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus prevents relapse of nephrotic syndrome in patients with idiopathic membranous glomerulonephritis;Secondary Objective: To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus is more effective at decreasing proteinuria and maintaining renal function.;Primary end point(s): Prevention of relapse of proteinuria on withdrawal of tacrolimus therapy, (all patients followed for at least 6 months post cessation of tacrolimus).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026