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

Sponsored by:	Nanjing University School of Medicine
Information provided by:	Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00298506

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: FK506 Drug: MMF Drug: CTX

Drug Information available for: Cyclophosphamide Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
C: Active Comparator C stands for CTX treatment.	Drug: CTX Cyclophosphamide,1.0g/mon,6m
M: Experimental M stands for multitargeted therapy (FK506 combined with MMF).	Drug: FK506 Tacrolimus,4mg/d,1/12h Drug: MMF mycophenolate mofetil,1.0g/d,1/12h

Detailed Description:

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.
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.
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:

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).
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.
Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298506

Contacts

Contact: Haitao Zhang, M.D.

86-25-80860218

haitaozh@yahoo.com.cn

Locations

China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Haitao Zhang, M.D. 86-25-80860218 ext 86-25-84801992 haitaozh@yahoo.com.cn
Principal Investigator: Lei-Shi Li, M.D.

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

Publications indexed to this study:

Bao H, Liu ZH, Xie HL, Hu WX, Zhang HT, Li LS. Successful treatment of class V+IV lupus nephritis with multitarget therapy. J Am Soc Nephrol. 2008 Oct;19(10):2001-10. Epub 2008 Jul 2.

Responsible Party:	Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine )
Study ID Numbers:	NJCT-0601
Study First Received:	March 1, 2006
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00298506
Health Authority:	China: State Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:

Tacrolimus
Mycophenolate mofetil
Cyclophosphamide
Lupus nephritis
Treatment

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Lupus Nephritis
Nephritis

Mycophenolic Acid
Mycophenolate mofetil
Connective Tissue Diseases
Tacrolimus
Cyclophosphamide
Kidney Diseases

Additional relevant MeSH terms:

Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009