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

NCT01328834 | Completed Phase 3 DMC

• 1 other identifier: SYSU-PRGLN-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Nephritis, Lupus

Keywords

Nephritis, Lupus; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• Remission rate (complete or partial remission)

  6 months after therapy

Secondary Outcomes (5)

• The changes of proteinuria

  every 3 months up to 6 months

• SLEDAI scores

  every 3 months up to 6 months

• Number of participants with adverse events as a measure of safety and tolerability

  every 3 months up to 6 months

• The changes of renal function

  every 3 months up to 6 months

• Relapse

  every 3 months up to 6 months

Study Arms (1)

ADVAGRAF

EXPERIMENTAL

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

Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)

Interventions

Tacrolimus Sustained-release Capsules (ADVAGRAF) DRUG

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

Also known as: ADVAGRAF: Tacrolimus Sustained-release Capsules

ADVAGRAF

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of either sex, 14-65 years of age;
• Diagnosis of SLE according to the ACR criteria (1997);
• 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;
• Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
• 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);
• Provision of written informed consent by subject or guardian

You may not qualify if:

• Inability or unwillingness to provide written informed consent ;
• 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;
• Scr \> 4mg/dl (354umol/L);
• Needing pulse intravenous MP or intravenous immunoglobulin;
• Lupus encephalopathy;
• Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);
• History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;
• Known hypersensitivity or contraindication to tacrolimus, corticosteroids
• Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;
• Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening;
• Pregnancy, nursing or use of a non-reliable method of contraception.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University IRB

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yu Xueqing, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: April 5, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 3, 2011

Record last verified: 2011-10

Locations

CN (1)