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

N

Nanjing University School of Medicine

Status

Completed

Conditions

Lupus Nephritis

Treatments

Drug: Tripterygium

Study type

Interventional

Funder types

Other

Identifiers

NCT00881309
NJCT-0902

Details and patient eligibility

About

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

Full description

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.

Enrollment

94 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients who signed written informed consent form;

  2. SLE patient, aged between 18-60 years, female or male;

  3. Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy;

  4. All patients received induction therapy for 6-12 months, including MMF, CTX, FK506 or multi-target therapy;

  5. 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

  1. Patients who didn't sign written informed consent form or could not obey the protocol;
  2. Patients who didn't received the CR or PR criterion;
  3. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit;
  4. WBC < 3000/mm3 in peripheral blood;
  5. Patients with abnormal of central nervous system.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

94 participants in 1 patient group

immunosuppressor
Experimental group
Treatment:
Drug: Tripterygium

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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