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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
History of Changes
  Purpose

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 Intervention Phase
Nephritis, Lupus
 Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Remission rate (complete or partial remission) [ Time Frame: 6 months after therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328834

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

No publications provided

Responsible Party: Xueqing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01328834     History of Changes
Other Study ID Numbers: SYSU-PRGLN-003
Study First Received: February 1, 2011
Last Updated: November 1, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013