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NCT Number: NCT01056237

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Nephrology, Jinling Hospital

Nanjing, Jiangsu, 210002, China

About this study

Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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. -

Treatment and study plan

Multi-target therapy

Drug

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

Other names: Tacrolimus+mycophenolate mofetil

azathioprine

Drug

1.0-2.0mg/kg/d

Other names: Aza

Primary outcomes

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

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Zhi-Hong Liu, M.D.

Other

Registry information

Official study title

Research Institute of Nephrology, Jinling Hospital,

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2010
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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