Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis

NCT01056237 | Completed DMC

• 1 other identifier: NJCT-1002
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.

  18 months

Study Arms (2)

Multi-target therapy

EXPERIMENTAL

(Tarcrolimus+mycophenolate mofetil)

Drug: Multi-target therapy

Azathioprine

ACTIVE COMPARATOR

Aza

Drug: Azathioprine

Interventions

Multi-target therapy DRUG

Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)

Also known as: Tacrolimus+mycophenolate mofetil

Multi-target therapy

Azathioprine DRUG

1.0-2.0mg/kg/d

Also known as: Aza

Azathioprine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who signed written informed consent form
• SLE patient, aged between 18-65 years, female or male;
• Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
• All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
• Patients were recruited when received partial remission or complete remission after 6 months induction therapy.
• Complete remission: proteinuria \<0.4 g/24h, negative urine sediment, serum albumin \>35 g/L, elevated scr \<0.3mg/dl, no extra-renal complications; Partial remission: proteinuria \<1.0 g/24h, urine RBC \<50X104/ml without casts, serum albumin \> 30 g/L, elevated Scr \<0.3mg/dl,no extra-renal complications.

You may not qualify if:

• Patients who didn't sign written informed consent form or could not obey the protocol.
• Patients who didn't received the CR or PR criterion.
• Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
• WBC \<3000/mm3 in peripheral blood .
• Patients with central nervous system symptoms. -

Sponsors & Collaborators

• Zhi-Hong Liu, M.D.: lead

Study Sites (1)

Research Institute of Nephrology, Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Azathioprine

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)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• zhihong Liu, Master

  Research Institute of Nephrology, Jinling Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 26, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

CN (1)