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

Phase 4CompletedNCT01203709

Tuen Mun Hospital20 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lupus Nephritis

Interventions

low dose combination of MMF and TacDRUG

mycophenolate mofetil 500mg BID + tacrolimus 2mg BID

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tuen Mun Hospital

Hong Kong, China

Outcomes

Primary Outcomes

Clinical remission rate

Time frame: 12 months

Secondary Outcomes

Adverse events

adverse events experienced by patients as a measure of tolerability

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.