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

Lupus Nephritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298506
• Other study ID #: NJCT-0601
• Status: Completed
• Phase: N/A
• First received: March 1, 2006
• Last updated: September 28, 2011
• Start date: September 2005
• Est. completion date: June 2009

Study information

• Verified date: September 2011
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 50 Years

Eligibility

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 ?, ?, ? + ?, ? + ? 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Multitherapy
Tacrolimus,4mg/d, MMF 1.0g/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital	Nanjing	Jiangsu
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN		18 months	Yes
Secondary	To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses		18 months	Yes