Text Size

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

This study is currently recruiting participants.
Verified October 2012 by Tuen Mun Hospital
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT01203709
First received: September 15, 2010
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Lupus Nephritis
 Drug: low dose combination of MMF and Tac
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tuen Mun Hospital:

Primary Outcome Measures:
  • Clinical remission rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    adverse events experienced by patients as a measure of tolerability


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination treatment
treatment arm
 Drug: low dose combination of MMF and Tac
mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
Other Name: Cellcept and Prograf

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203709

Contacts
Contact: CC Mok, MD, FRCP (852) 2468 5389 ccmok2006@gmail.com

Locations
China
Tuen Mun Hospital Recruiting
Hong Kong, China
Contact: CC Mok, MD, FRCP     (852) 2468 5389     ccmok2006@gmail.com    
Sponsors and Collaborators
Tuen Mun Hospital
Investigators
Principal Investigator: CC Mok, MD, FRCP Tuen Mun Hospital, Hong Kong China
  More Information

No publications provided

Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT01203709     History of Changes
Other Study ID Numbers: NTWC/CREC/837/10
Study First Received: September 15, 2010
Last Updated: October 29, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:
lupus
nephritis
glomerulonephritis
nephropathy
refractory

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolate mofetil
Tacrolimus
 Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013