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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01328834
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : November 3, 2011
Information provided by:
Sun Yat-sen University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Nephritis, Lupus Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: ADVAGRAF
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase
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

Primary Outcome Measures :
  1. Remission rate (complete or partial remission) [ Time Frame: 6 months after therapy ]

Secondary Outcome Measures :
  1. The changes of proteinuria [ Time Frame: every 3 months up to 6 months ]
  2. SLEDAI scores [ Time Frame: every 3 months up to 6 months ]
    SLEDAI:Systemic Lupus Erythematosus Disease Activity Index (Bombardier et al, 1992).

  3. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: every 3 months up to 6 months ]
    Adverse events, including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.

  4. The changes of renal function [ Time Frame: every 3 months up to 6 months ]
  5. Relapse [ Time Frame: every 3 months up to 6 months ]

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01328834

China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University IRB
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Yu Xueqing, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Xueqing Yu, Sun Yat-sen University Identifier: NCT01328834     History of Changes
Other Study ID Numbers: SYSU-PRGLN-003
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: October 2011

Keywords provided by Sun Yat-sen University:
Nephritis, Lupus

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action