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Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01328834
First received: February 1, 2011
Last updated: November 1, 2011
Last verified: October 2011

February 1, 2011
November 1, 2011
January 2011
October 2011   (final data collection date for primary outcome measure)
Remission rate (complete or partial remission) [ Time Frame: 6 months after therapy ] [ Designated as safety issue: Yes ]
Remission rate (complete or partial remission) [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01328834 on ClinicalTrials.gov Archive Site
  • The changes of proteinuria [ Time Frame: every 3 months up to 6 months ] [ Designated as safety issue: Yes ]
  • SLEDAI scores [ Time Frame: every 3 months up to 6 months ] [ Designated as safety issue: Yes ]
    SLEDAI:Systemic Lupus Erythematosus Disease Activity Index (Bombardier et al, 1992).
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: every 3 months up to 6 months ] [ Designated as safety issue: Yes ]
    Adverse events, including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.
  • The changes of renal function [ Time Frame: every 3 months up to 6 months ] [ Designated as safety issue: Yes ]
  • Relapse [ Time Frame: every 3 months up to 6 months ] [ Designated as safety issue: Yes ]
  • proteinuria, renal function, relapse. [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
  • SLEDAI scores [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
    SLEDAI:Systemic Lupus Erythematosus Disease Activity Index (Bombardier et al, 1992).
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
    Adverse events, including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.
Not Provided
Not Provided
 
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
Not Provided

This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nephritis, Lupus
Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)
Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.
Other Name: ADVAGRAF: Tacrolimus Sustained-release Capsules
Experimental: ADVAGRAF
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase
Intervention: Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects of either sex, 14-65 years of age;
  2. Diagnosis of SLE according to the ACR criteria (1997);
  3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;
  4. Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
  5. proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 WBC/high power field (hpf) (excluding infection), > 5 RBC/hpf);
  6. Provision of written informed consent by subject or guardian

Exclusion Criteria:

  1. Inability or unwillingness to provide written informed consent ;
  2. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;
  3. Scr > 4mg/dl (354umol/L);
  4. Needing pulse intravenous MP or intravenous immunoglobulin;
  5. Lupus encephalopathy;
  6. Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);
  7. History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;
  8. Known hypersensitivity or contraindication to tacrolimus, corticosteroids
  9. Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;
  10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening;
  11. Pregnancy, nursing or use of a non-reliable method of contraception.
Both
14 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01328834
SYSU-PRGLN-003
Yes
Xueqing Yu, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Yu Xueqing, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP