A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients

NCT01316133 | Terminated Phase 4

• 1 other identifier: PRGLN-10-01-KOR
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 7

Brief Summary

This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.

Conditions

Lupus Nephritis

Keywords

Tacrolimus; Prograf; FK506; Proteinuria; Calcineurin inhibitor

Outcome Measures

Primary Outcomes (1)

• Remission rate

  Percentage of the patients who shows complete remission or partial remission

  24 weeks

Secondary Outcomes (4)

• Complete remission rate

  24 weeks

• Change from baseline in urine protein to creatinine ratio

  Baseline, 4 weeks, 12 weeks and 24 weeks

• Change from baseline in serum creatinine

  Baseline, 4 weeks, 12 weeks and 24 weeks

• Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs

  for 24 weeks

Study Arms (1)

Tacrolimus group

EXPERIMENTAL

Oral

Drug: tacrolimus

Interventions

tacrolimus DRUG

oral

Also known as: Prograf, FK506

Tacrolimus group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
• Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
• Patients with refractory lupus nephritis
• Proteinuria ≥ 0.5 g/day
• Patients who took steroid ≥ 20 mg/day over one month prior to the study
• Patients who failed a first-line therapy (non-responders to steroid monotherapy)

You may not qualify if:

• Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
• Patients who received tacrolimus in the past (excluding drugs for external use)
• Patients who used other immunosuppressants within 4 weeks before initiation of the study
• Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
• Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
• Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
• Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
• Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (7)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Lupus Nephritis; Proteinuria

Interventions

Tacrolimus

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; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 16, 2011
• Study Start: April 19, 2011
• Primary Completion: April 8, 2016
• Study Completion: April 8, 2016
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)