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

NCT00302549 | Completed DMC

• 1 other identifier: NJCT-0602
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To compare the efficacy of FK506 vs intravenous cyclophosphamide pulses in the treatment of class III-IV LN.
2. 2.To compare the safety and tolerability of FK506 vs intravenous cyclophosphamide pulses in the treatment of class III-IV LN.
3. 3.To explore the dosing of FK506 and its effective range of blood concentration.

Conditions

Lupus Nephritis

Keywords

Tacrolimus; Cyclophosphamide; Treatment; Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• To compare the safety and tolerability of FK506 vs intravenous cyclophosphamide pulses in the treatment of class III-IV LN and to explore the dosing of FK506 and its effective range of blood concentration.

  6 months

Study Arms (1)

FK506

ACTIVE COMPARATOR

Drug: FK506

Interventions

FK506 DRUG

FK506,0.1mg/kg/d

Also known as: Tacrolimus,Prograf

FK506

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Patients with serum creatinine \> 3 mg/dl（265μmol/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 glucose, with a fasted 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.
• Patients who use Erythromycin, Fluconazole, Ethinylestradiol, Rifampicin, and Carbamazepine.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Lei-shi Li, M.D.

  Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 14, 2006
• Study Start: May 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: February 1, 2006
• Last Updated: May 27, 2010

Record last verified: 2008-07

Locations

CN (1)