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

March 3, 2014 updated by: Chi Chiu Mok, Tuen Mun Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination treatment
treatment arm
Drug: low dose combination of MMF and Tac
mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
Other Names:
  • Cellcept and Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical remission rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 12 months
adverse events experienced by patients as a measure of tolerability
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Investigators

  • Principal Investigator: CC Mok, MD, FRCP, Tuen Mun Hospital, Hong Kong China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTWC/CREC/837/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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