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Lupus NephritisPhase 3NCT02457221

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

A Phase 3 study testing Tacrolimus capsules, Cyclophosphamide injections and Prednisone in people with Lupus Nephritis, run by Astellas Pharma China, Inc. at 35 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lupus Nephritis
What is being tested?
Tacrolimus capsules, Cyclophosphamide injections and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
35 sitesChina
Study dates
10 Mar 2015to 10 Sep 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • Site CN00030

    Beijing, Beijing Municipality

  • Site CN00034

    Beijing, Beijing Municipality

  • Site CN00026

    Changchun, Jilin

  • Site CN00042

    Changchun, Jilin

  • Site CN00027

    Changsha, Hunan

  • Site CN00050

    Changsha, Hunan

  • Site CN00002

    Chengdu, Sichuan

  • Site CN00003

    Chengdu, Sichuan

  • Site CN00005

    Dalian, Liaoning

  • Site CN00056

    Guangzhou, Guangdong

  • Site CN00010

    Hangzhou, Zhejiang

  • Site CN00043

    Hefei, Anhui

  • Site CN00045

    Liuzhou, Guangxi

  • Site CN00012

    Nanjing, Jiangsu

  • Site CN00013

    Nanjing, Jiangsu

  • Site CN00025

    Nanjing, Jiangsu

  • Site CN00037

    Nanning, Guangxi

  • Site CN00038

    Nanning, Guangxi

  • Site CN00032

    Qingdao, Shandong

  • Site CN00001

    Shanghai, Shanghai Municipality

  • Site CN00014

    Shanghai, Shanghai Municipality

  • Site CN00015

    Shanghai, Shanghai Municipality

  • Site CN00018

    Shenyang, Liaoning

  • Site CN00019

    Shenyang, Liaoning

  • Site CN00017

    Shenzhen, Guangdong

  • Site CN00020

    Shijiazhuang, Hebei

  • Site CN00047

    Shijiazhuang, Hebei

  • Site CN00052

    Taiyuan, Shanxi

  • Site CN00021

    Tianjin, Tianjin Municipality

  • Site CN00044

    Ürümqi, Xinjiang

  • Site CN00023

    Wuhan, Hubei

  • Site CN00024

    Wuhan, Hubei

  • Site CN00049

    Wuxi, Jiangsu

  • Site CN00041

    Xiamen, Fujian

  • Site CN00028

    Zhengzhou, Henan

Other trials in China

About this study

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

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.

Read the detailed description

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

Conditions
Lupus Nephritis
Being tested
Tacrolimus capsules, Cyclophosphamide injections, Prednisone
Keywords
Tacrolimus, Cyclophosphamide, Prograf, lupus nephritis
Medical subject headings
Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tacrolimus capsulesDrug

    Also called Prograf

    oral

  • Cyclophosphamide injectionsDrug

    intravenous injection

  • PrednisoneDrug

    oral

Study groups in NCT02457221
Study groupRoleWhat they receive
Tacrolimus groupExperimentalTacrolimus capsules + steroid
Receives: Drug: Tacrolimus capsules; Drug: Prednisone
Cyclophosphamide groupActive comparatorCyclophosphamide injections + steroid
Receives: Drug: Cyclophosphamide injections; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission rate (complete remission + partial remission)

    complete remission: urine protein < 0.5g/24hr, and serum albumin≥3.5g/dl, and stable renal function (Scr increase ≤ 15% baseline value) partial remission: urine protein 0.5-3.5g/24hr (≥ 0.5 g/24hr and < 3.5 g/24hr), and urine protein decreased by >50% comparing with the baseline, and serum albumin ≥ 3.0g/dl, and stable renal function (Scr increase ≤ 15% baseline value)

    Measured: at 24 weeks

Secondary outcomes (18)

  1. 24-hour urine protein

    Measured: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24

  2. Change of 24-hour urine protein from baseline

    Measured: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24

  3. Serum albumin

    Measured: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24

  4. Change of Serum albumin from baseline

    Measured: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24

  5. Serum creatinine

    Measured: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24

  6. Change of Serum creatinine from baseline

    Measured: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24

  7. eGFR comparing with baseline

    eGFR: Estimated Glomerular Filtration Rate

    Measured: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24

  8. Percentage of patients converted to other immunosuppressive therapy

    Measured: during 24 weeks

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

    Measured: during 24 weeks

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

    ANA: Antinuclear Antibody

    Measured: during 24 weeks

  11. SLE-DAI

    SLE-DAI: Systemic Lupus Erythematosus - Disease Activity Index

    Measured: at Week 4, 12 and 24

  12. Immune parameters assessed by ESR, C3, C4 and dsDNA

    ESR: Erythrocyte Sedimentation Rate, C3, C4: Complement C3, C4, dsDNA: Anti-Double-Stranded DNA Antibodies

    Measured: at Week 4, 12 and 24

  13. Change of SLE-DAI from baseline

    Measured: at Week 4, 12 and 24

  14. Change of immune parameters from baseline

    Measured: at Week 4, 12 and 24

  15. Renal biopsy AI (Active Index)

    Measured: at Week 24

  16. CI (Chronic Index)

    Measured: at Week 24

  17. Change of Renal biopsy AI (Active Index) from baseline

    Measured: at Week 24

  18. Change of CI (Chronic Index) from baseline

    Measured: at Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2015 (estimated)
  2. Study start10 Mar 2015
  3. Primary completion10 Sep 2018
  4. Study completion10 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02457221
Sponsor's protocol ID
F506-CL-0912
Status last verified
Oct 2024
First submitted
22 May 2015
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Zheng Z, Zhang H, Peng X, Zhang C, Xing C, Xu G, Fu P, Ni Z, Chen J, Xu Z, Zhao MH, Li S, Huang X, Miao L, Chen X, Liu B, He Y, Li J, Liu L, Kadeerbai H, Liu Z, Liu Z. Effect of Tacrolimus vs Intravenous Cyclophosphamide on Complete or Partial Response in Patients With Lupus Nephritis: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e224492. doi: 10.1001/jamanetworkopen.2022.4492.

    PubMed 35353167

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tacrolimus capsules, Cyclophosphamide injections and Prednisone in people with Lupus Nephritis, run by Astellas Pharma China, Inc. at 35 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission rate (complete remission + partial remission) (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02457221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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