Status:
COMPLETED
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis
Lead Sponsor:
Tuen Mun Hospital
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- Active nephritis documented by renal biopsy within 24 months of entry;
- 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;
- Serum creatinine (Scr) less than 200umol/L.
Exclusion
- Previous intolerance to either MMF/Tac;
- Scr \>200umol/L;
- Informed consent unavailable.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01203709
Start Date
August 1 2010
End Date
February 1 2013
Last Update
March 4 2014
Active Locations (1)
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1
Tuen Mun Hospital
Hong Kong, China