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

NCT ID: NCT01328834

Last Updated: 2011-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Nephritis, Lupus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADVAGRAF

Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase

Group Type EXPERIMENTAL

Tacrolimus Sustained-release Capsules (ADVAGRAF)

Intervention Type DRUG

Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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ADVAGRAF: Tacrolimus Sustained-release Capsules

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Sun Yat-sen University

Principal Investigators

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Yu Xueqing, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Locations

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The First Affiliated Hospital of Sun Yat-sen University IRB

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSU-PRGLN-003

Identifier Type: -

Identifier Source: org_study_id