Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis

Phase 4

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: low dose combination of MMF and Tac

• Registration Number: NCT01203709
• Lead Sponsor: Tuen Mun Hospital

Brief Summary

A trial of combination of two drugs for the treatment of refractory lupus nephritis.

Detailed Description

Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Active nephritis documented by renal biopsy within 24 months of entry;
2. Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
3. Serum creatinine (Scr) less than 200umol/L.

Exclusion Criteria

1. Previous intolerance to either MMF/Tac;
2. Scr >200umol/L;
3. Informed consent unavailable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination treatment	low dose combination of MMF and Tac	treatment arm

Primary Outcome Measures

Name	Time	Method
Clinical remission rate	12 months

Secondary Outcome Measures

Name	Time	Method
Adverse events	12 months	adverse events experienced by patients as a measure of tolerability

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇨🇳 Hong Kong, China