- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00425438
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
September 22, 2014 updated by: Hoffmann-La Roche
A Randomized, Open-label Study to Compare the Effect of CellCept Plus Corticosteroids, and Cyclophosphamide Plus Corticosteroids Followed by Azathioprine, on Remission Rate in Patients With Lupus Nephritis
This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis.
Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2
monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks.
Response rate will be assessed at the end of the induction phase, and at the end of study.
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100029
-
Beijing, China, 100853
-
Beijing, China, 100005
-
Guangzhou, China, 510080
-
Guangzhou, China, 510515
-
Hangzhou, China, 310003
-
Nanjing, China, 210008
-
Shanghai, China, 200025
-
Shanghai, China, 200001
-
Shanghai, China, 200003
-
Shenyang, China, 110001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, 18-75 years of age;
- systemic lupus erythematosus;
- histological diagnosis of lupus nephritis.
Exclusion Criteria:
- not in need of immunosuppressive treatment (in addition to corticosteroids);
- continuous dialysis starting >2 weeks before randomization, with an anticipated duration of >8 weeks;
- previous or planned kidney transplant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mycophenolate Mofetil
Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID from Weeks 32 to 48.
Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.
|
0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48
Other Names:
0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48
Other Names:
|
Active Comparator: Cyclophosphamide/Azathioprine
Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (mm^3) every 4 weeks from Weeks 5 through 24.
Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for subjects with a body weight of more than 70 kg from Weeks 25 through 48.
Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.
|
0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48
Other Names:
100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48
0.75 g/m^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0
g/m^2 to maintain a minimum WBC count of ≥ 2500 per mm^3 from Weeks 5 through 24
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event
Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.
|
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response
Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
The median time, in months, to CR was defined as the time from randomization to CR event.
|
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Percentage of Participants With Treatment Response Event by End of Treatment
Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.
|
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR)
Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.
|
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Percentage of Participants Terminating Treatment
Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
|
Time to Treatment Failure
Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.
|
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
January 22, 2007
First Submitted That Met QC Criteria
January 22, 2007
First Posted (Estimate)
January 23, 2007
Study Record Updates
Last Update Posted (Estimate)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 22, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Prednisolone
- Cyclophosphamide
- Azathioprine
- Mycophenolic Acid
Other Study ID Numbers
- ML19978
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lupus Nephritis
-
Imperial College LondonKarolinska Institutet; Ohio State University; Dutch Working Party on Systemic... and other collaboratorsTerminatedSystemic Lupus Erythematosus, Lupus NephritisUnited Kingdom
-
Sun Yat-sen UniversityCompleted
-
Peking UniversityCompleted
-
University Hospital, GrenobleInstitut de Biologie Structurale GrenobleCompletedSystemic Lupus Erythematosus NephritisFrance
-
Peking Union Medical College HospitalUnknownNephritis, LupusChina
-
Artiva Biotherapeutics, Inc.RecruitingLupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class IIIUnited States
-
Kyverna TherapeuticsRecruitingLupus Nephritis | Lupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class IIIGermany
-
Minia UniversityNot yet recruitingmfERG in Lupus NephritisEgypt
-
Kyverna TherapeuticsRecruitingLupus Nephritis | Lupus Nephritis - World Health Organization (WHO) Class III | Lupus Nephritis - WHO Class IVUnited States
-
Centre Hospitalier Universitaire, AmiensCompletedLupus Nephritis | Systemic Lupus Erythematosus (SLE)France
Clinical Trials on Mycophenolate Mofetil
-
University of GiessenNovartis; Hoffmann-La Roche; Astellas Pharma Inc; Heidelberg UniversityCompletedPolyomavirus InfectionsGermany
-
Novartis PharmaceuticalsCompletedRenal TransplantationUnited States
-
Nanjing University School of MedicineCompletedNephritis | Henoch-Schoenlein PurpuraChina
-
Children's Hospital of Fudan UniversityShanghai Children's Hospital; Shanghai Children's Medical Center; Xinhua Hospital...WithdrawnSteroid-Dependent Nephrotic Syndrome | Frequently Relapsing Nephrotic SyndromeChina
-
Nanjing University School of MedicineCompletedVasculitis | Anti-Neutrophil Cytoplasmic AntibodyChina
-
Panacea Biotec LtdCompletedHealthy VolunteersIndia
-
Teva Branded Pharmaceutical Products R&D, Inc.ParexelTerminatedStable Renal Transplant Recipients
-
Panacea Biotec LtdCompletedHealthy VolunteersIndia
-
Fred Hutchinson Cancer CenterUniversity of WashingtonCompleted
-
Samsung Medical CenterUnknown