A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.

NCT00425438 | Terminated Phase 3 Results

• 1 other identifier: ML19978
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event

  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 Outcomes (5)

• Complete Response

  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

  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)

  Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48

• Percentage of Participants Terminating Treatment

  Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48

• Time to Treatment Failure

  Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48

Study Arms (2)

Mycophenolate Mofetil

EXPERIMENTAL

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.

Drug: Mycophenolate Mofetil; Drug: Corticosteroids

Cyclophosphamide/Azathioprine

ACTIVE COMPARATOR

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.

Drug: Corticosteroids; Drug: Azathioprine; Drug: Cyclophosphamide

Interventions

Mycophenolate Mofetil DRUG

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

Also known as: CellCept

Mycophenolate Mofetil

Corticosteroids DRUG

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

Also known as: Prednisolone

Cyclophosphamide/Azathioprine; Mycophenolate Mofetil

Azathioprine DRUG

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

Cyclophosphamide/Azathioprine

Cyclophosphamide DRUG

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

Cyclophosphamide/Azathioprine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18-75 years of age;
• systemic lupus erythematosus;
• histological diagnosis of lupus nephritis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

Unknown Facility

Beijing, 100005, China

Location

Unknown Facility

Beijing, 100029, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Guangzhou, 510080, China

Location

Unknown Facility

Guangzhou, 510515, China

Location

Unknown Facility

Hangzhou, 310003, China

Location

Unknown Facility

Nanjing, 210008, China

Location

Unknown Facility

Shanghai, 200001, China

Location

Unknown Facility

Shanghai, 200003, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Shenyang, 110001, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid; Adrenal Cortex Hormones; Prednisolone; Azathioprine; Cyclophosphamide

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

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Limitations and Caveats

The study was terminated early due to administrative reasons.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

CN (11)