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

Lupus Nephritis Clinical Trial

Official title:

Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203709
• Other study ID #: NTWC/CREC/837/10
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: March 3, 2014
• Start date: August 2010
• Est. completion date: February 2013

Study information

• Verified date: March 2014
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• low dose combination of MMF and Tac
mycophenolate mofetil 500mg BID + tacrolimus 2mg BID

Locations

Country	Name	City	State
China	Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission rate		12 months	No
Secondary	Adverse events	adverse events experienced by patients as a measure of tolerability	12 months	Yes