To Compare the Efficacy and Safety of FK506 vs IVC in the Treatment of Class III-IV LN

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

1. To compare the efficacy of FK506 vs intravenous cyclophosphamide pulses in the treatment of class III-IV LN.

2. To compare the safety and tolerability of FK506 vs intravenous cyclophosphamide pulses in the treatment of class III-IV LN.

3. To explore the dosing of FK506 and its effective range of blood concentration.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nanjing University School of Medicine
• Collaborator: Sun Yat-sen University
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. Female patients with a diagnosis of Systemic Lupus Erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982 (Appendix 1) aged between 18-65 years, and whose score of SLE-DAI (Disease Active Index, Appendix 2) is greater than 10.

2. Patients diagnosed to have class III or IV LN by renal biopsy, according to the WHO classification criteria (1995, Appendix 3) within 3 month and have significant active pathological lesion.

3. Patients with a proteinuria ≥ 2g/24h, and an active urine sediment (Hematuria with white cells and casts in urine).

4. Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.

Exclusion Criteria:

1. Patients who have received treatment of cytotoxic drugs such as CTX, Mycophenolate mofetil (MMF) cyclosporine for more than 1 week within three months, but Azathioprine (AZa) are accepted.

2. Patients with serum creatinine > 3 mg/dl（265μmol/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 glucose, with a fasted 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.

8. Patients who use Erythromycin, Fluconazole, Ethinylestradiol, Rifampicin, and Carbamazepine.