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A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lupus Nephritis

Intervention: Tacrolimus capsules (Drug); Cyclophosphamide injections (Drug); Prednisone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Astellas Pharma China, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma China, Inc.

Overall contact:
Astellas Pharma China, Inc., Phone: +(86) 10-85216333, Email: Astellas.registration@astellas.com

Summary

The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.

Clinical Details

Official title: A Phase III, Randomized, Open, Parallel-controlled, Multi-center Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Remission rate (complete remission + partial remission)

Secondary outcome:

24-hour urine protein

Change of 24-hour urine protein from baseline

Serum albumin

Change of Serum albumin from baseline

Serum creatinine

Change of Serum creatinine from baseline

eGFR comparing with baseline

Percentage of patients converted to other immunosuppressive therapy

Percentage of patients with serum creatinine rising to two times of the baseline

Percentage of patients with dsDNA and ANA converting from positive to negative

SLE-DAI

Immune parameters assessed by ESR, C3, C4 and dsDNA

Change of SLE-DAI from baseline

Change of immune parameters from baseline

Renal biopsy AI (Active Index)

CI (Chronic Index)

Change of Renal biopsy AI (Active Index) from baseline

Change of CI (Chronic Index) from baseline

Detailed description: This is a randomized, open, 1: 1 parallel controlled, multi-center, non-inferiority clinical study.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18. 5≤Body Mass Index (BMI) <27;

- Diagnosed as systemic lupus erythematosus (based on American Rheumatism Association

Diagnostic Criteria 1997)

- Diagnosed as III, IV, V, III + V, IV + V lupus nephritis (according to the LN

classification in International Society of Nephrology and Renal Pathology Society (ISN/RPS) 2003) within 24 weeks before enrollment with renal biopsy;

- 24-hour urine protein ≥ 1. 5g, Scr<260umol/L (or 3mg/dL)

Exclusion Criteria:

- Class II or VI lupus nephritis or renal biopsy chronic index (CI) > 3 or with TMA;

- Received immunosuppressants (mycophenolate mofetil (MMF), cyclosporine, methotrexate,

mechlorethamine, chlorambucil, tripterygium preparations, leflunomide etc.) treatment with a duration of more than one week within 30 days prior to enrollment;

- Received tacrolimus (except for topical use) or cyclophosphamide treatment within 30

days prior to enrollment;

- Received a course of methylprednisolone (MP) pulse therapy or gamma globulin

treatment or plasma exchange within 30 days prior to enrollment;

- Patients with history of allergies to tacrolimus, cyclophosphamide or

methylprednisolone;

- Pregnancy, lactation or patient unwilling to take contraceptive measures;

- Patients with estimated maintenance dialysis for more than eight weeks; or dialysis

for more than two weeks prior to entering observation;

- Patients received kidney transplantation or plan to have kidney transplantation

recently;

- Serum creatinine (Scr) ≥260umol/L (or 3mg/dL) or creatinine clearance rate (Ccr) <

30ml/(min. 1.73m2); according to Cockcroft-Gault formula: Ccr (ml/sec) = [(140- age)× Weight (kg)] × K / [72×Scr (umol/L) ×0. 6786], Female K = 0. 85, Male K = 1. 0;

- Patients suffering from liver dysfunction (aspartate aminotransferase (AST) or

alanine aminotransferase (ALT) more than 3 times the upper limit of normal lab value) or bilirubin more than 3 times the upper limit of normal lab value;

- Patients diagnosed with diabetes;

- History of gastrointestinal bleeding or pancreatitis within 3 months;

- Uncontrollable hyperkalemia after dietary therapy or reduction of potassium treatment

(exceed the upper limit of normal lab value);

- Patients suffering from lupus pneumonia or lung injury;

- Patients with anemia (hemoglobin <7g/dl) or bone marrow suppression (WBC <3. 0×109/L,

and/or neutrophils <1. 5×109/L, and/or platelets <50×109/L) not secondary to systemic lupus erythematosus;

- With congenital heart disease, arrhythmia, heart failure or other severe

cardiovascular diseases;

- With refractory hypertension (defined as blood pressure still exceeds 180/110 mmHg

despite taking three different types of antihypertensive drugs [one of them is diuretic] simultaneously);

- Patients with recurrent tumors within 5 years;

- Severe infection that requires intravenous antibiotics within 2 weeks prior to

enrollment;

- Patients with infection of hepatitis B virus or hepatitis C virus; patients with

active tuberculosis; patients with severe immunodeficiency diseases (including active cytomegalovirus infection (positive CMV IgM antibody), or human immunodeficiency virus (HIV) infection, etc.);

- Patients with lupus encephalopathy or other life-threatening complication of systemic

lupus erythematosus;

- Patients participated in other clinical trials within three months before enrollment

Locations and Contacts

Astellas Pharma China, Inc., Phone: +(86) 10-85216333, Email: Astellas.registration@astellas.com

Site: 11, Beijing, China; Recruiting

Site: 12, Beijing, China; Recruiting

Site: 17, Fujian, China; Recruiting

Site: 3, Guangdong, China; Recruiting

Site: 14, Guangxi, China; Recruiting

Site: 13, Guangzhou, China; Recruiting

Site: 10, Henan, China; Recruiting

Site: 15, Hubei, China; Recruiting

Site: 16, Hubei, China; Recruiting

Site: 18, Hunan, China; Recruiting

Site: 4, Jiangsu, China; Recruiting

Site: 8, Jiangsu, China; Recruiting

Site: 9, Jilin, China; Recruiting

Site: 7, Liaoning, China; Recruiting

Site: 2, Shandong, China; Recruiting

Site: 5, Shandong, China; Recruiting

Site: 6, Shanghai, China; Recruiting

Site: 1, Sichuan, China; Recruiting

Additional Information

Starting date: March 2015
Last updated: May 27, 2015

Page last updated: August 23, 2015

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