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A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT02457221•Astellas Pharma China, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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;
+12 more criteria

Locations (35)

Site CN00043

Hefei, Anhui, China

Site CN00030

Beijing, Beijing Municipality, China

Site CN00034

Beijing, Beijing Municipality, China

Site CN00041

Xiamen, Fujian, China

Site CN00056

Guangzhou, Guangdong, China

Site CN00017

Shenzhen, Guangdong, China

Site CN00045

Liuchow, Guangxi, China

Site CN00037

Nanning, Guangxi, China

Site CN00038

Nanning, Guangxi, China

Site CN00020

Shijiazhuang, Hebei, China

Key Dates

Start Date

March 10, 2015

Primary Completion Date

September 10, 2018

Completion Date

September 10, 2018

Last Updated

November 1, 2024

Enrollment

314

ACTUAL participants

Conditions

Lupus Nephritis

Interventions

Tacrolimus capsules

DRUG

Cyclophosphamide injections

DRUG

Prednisone

DRUG

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277

Lupus Nephritis

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RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Lupus Landmark Study: A Prospective Registry and Biorepository