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Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00298506
First received: March 1, 2006
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.


Condition Intervention
Lupus Nephritis
 Drug: Multitherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Prospective Study to Assess the Efficacy and Safety of FK506 Combined MMF in the Treatment of Class III，IV，V + IV or V + III Lupus Nephritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: September 2005
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FK506+MMF Drug: Multitherapy
Tacrolimus,4mg/d, MMF 1.0g/d
Other Names:
  • FK506,Prograf,Tacrolimus
  • MMF,cellcept,mycophenolate mofetil

Detailed Description:
  1. To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.
  2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.
  3. To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.
  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN).
  2. Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI〈 4，Scr〈 3 mg/dl.
  3. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
  4. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups.

Exclusion Criteria:

  1. Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months.
  2. Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L).
  3. Patients with severe infection or central nervous system symptoms.
  4. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
  5. Patients who have abnormal blood glucose, with a fasting blood glucose > 6.2 mmol/L or post meal blood glucose > 11.2 mmol/L.
  6. Patients who are pregnant or lactating.
  7. Patients who are known to be allergic to a macrolide.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298506

Locations
China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Study Director: Lei-Shi Li, M.D. Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  More Information

No publications provided by Nanjing University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zhi-Hong Liu, M.D., Research Institute of Nephrology, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00298506     History of Changes
Other Study ID Numbers: NJCT-0601
Study First Received: March 1, 2006
Last Updated: September 28, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
Tacrolimus
Mycophenolate mofetil
Cyclophosphamide
Lupus nephritis
Treatment

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 18, 2013