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Completed

NCT Number: NCT00881309

To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis

The purpose of this study is to:

* To access the efficacy of TW compared to Aza in the maintenance therapy for lupus nephritis * To investigate the safety and tolerability of TW versus Aza in the maintenance therapy for lupus nephritis

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Key information

Age range

18 year–60 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

Tripterygium (TW) is a Chinese traditional patent drugs in treating chronic glomerulonephritis. It has been used to treat lupus nephritis for many years with less side effects. We compare the efficacy and safety of TW vs Aza in the maintenance therapy of lupus nephritis.

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 18-60 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 received induction therapy for 6-12 months, including MMF, CTX, FK506 or multi-target therapy;
  • When recruited in the study, patients received partial remission or complete remission for 3 months;
  • Complete remission: proteinuria < 0.4 g/24h, negative urine sediment, serum albumin > 35 g/L, elevated scr < 0.3 mg/dl, no extra-renal complications;
  • Partial remission: proteinuria < 1.0 g/24h, urine RBC < 500000/ml without casts, serum albumin > 35 g/L, elevated scr <0.3 mg/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;
  • WBC < 3000/mm3 in peripheral blood;
  • Patients with abnormal of central nervous system.

Treatment and study plan

Tripterygium

Drug

TW 90mg/d

Primary outcomes

  1. complete remission rate

    Time frame: 2 years

Secondary outcomes

  1. renal relapse

    Time frame: 2 years

  2. partial remission

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Official study title

To Compare the Efficacy and Safety of Tripterygium (TW) vs Aza in the Maintenance Therapy for Lupus Nephritis

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2009
Registry last updated
May 18, 2011

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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