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

Tuen Mun Hospital

Status and phase: Completed; Phase 4

Conditions: Lupus Nephritis

Treatments: Drug: low dose combination of MMF and Tac

Study type: Interventional

Funder types: Other

Identifiers

NCT01203709

NTWC/CREC/837/10

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Combination treatment

Experimental group

Description:

treatment arm

Treatment:

Drug: low dose combination of MMF and Tac