A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00282347
• Date of registration: 24/01/2006
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis LUNAR
• Scientific title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis
• Date of first enrolment: January 2006
• Target sample size: 144
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00282347
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Canada, Mexico, United States

Contacts

• Name: Paul Brunetta, MD
• Affiliation: Genentech, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of systemic lupus erythematosus (SLE) according to current American College
of Rheumatology (ACR) criteria.

- Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS)
2003 Class III or IV lupus nephritis (LN), with either active or active/chronic
disease.

- Proteinuria.

- 16-75 years of age.

Exclusion Criteria:

- Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis,
stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and
resulting from SLE.

- Unstable subjects with thrombocytopenia experiencing or at high risk for developing
clinically significant bleeding or organ dysfunction requiring therapies such as
plasmapheresis or acute blood or platelet transfusions.

- Lack of peripheral venous access.

- Pregnancy or lactation.

- History of severe allergic or anaphylactic reactions to monoclonal antibodies.

- Significant or uncontrolled medical disease in any organ system not related to SLE or
LN, which, in the investigator's opinion, would preclude subject participation.

- Concomitant chronic conditions, excluding SLE (eg, asthma, Crohn's disease) that
require oral or systemic corticosteroid use in the 52 weeks prior to screening.

- History of renal transplant.

- Known human immunodeficiency virus (HIV) infection.

- Known active infection of any kind (but excluding fungal infection of nail beds) or
any major episode of infection requiring hospitalization or treatment with intravenous
anti-infectives within 4 weeks of randomization or oral anti-infectives within 2 weeks
of randomization.

- History of deep space infection within 1 year of screening.

- History of serious recurrent or chronic infection.

- History of cancer, including solid tumors, hematological malignancies, and carcinoma
in situ (except basal cell carcinomas of the skin that have been treated or excised
and have resolved).

- Currently active alcohol or drug abuse or history of alcohol or drug abuse within 52
weeks prior to screening.

- Major surgery requiring hospitalization within 4 weeks of screening (excluding
diagnostic surgery).

- Treatment with cyclophosphamide or calcineurin inhibitors within the 90 days prior to
screening.

- Use of mycophenolate mofetil (MMF) at a dose of > 2 grams daily for longer than the 90
days prior to screening.

- Intolerance or history of allergic reaction to MMF.

- Intolerance or history of allergic reaction to both angiotensin-converting enzyme
(ACE) inhibitors and angiotensin-receptor blockers.

- Use of oral prednisone (or corticosteroid equivalent) at a dose of > 20 mg/day for
longer than the 14 days prior to screening.

- Previous treatment with CAMPATH-1H (alemtuzumab).

- Previous treatment with a B-cell targeted therapy.

- Treatment with any investigational agent (including biologic agents approved for other
indications) within 28 days of the start of the screening period or 5 half-lives of
the investigational drug (whichever is longer).

- Receipt of a live vaccine within the 28 days prior to screening.

- Intolerance or contraindication to oral or IV corticosteroids.

- Current therapy with a nonsteroidal anti-inflammatory agent.

- Positive hepatitis B sAg or hepatitis C serology.



Age minimum: 16 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Intervention(s)

Drug: Placebo

Drug: Diphenhydramine

Drug: Rituximab

Drug: Acetaminophen

Drug: Methylprednisolone

Drug: Mycophenolate mofetil

Drug: Prednisone

Primary Outcome(s)

Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Time to Achieve a Complete Renal Response [Time Frame: Baseline to Week 52]

Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52 [Time Frame: Week 24 to Week 52]

Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52 [Time Frame: Baseline to Week 52]

Change From Baseline in Anti-double-stranded DNA at Week 52 [Time Frame: Baseline to Week 52]

Percentage of Participants Who Achieved a Complete Renal Response at Week 52 [Time Frame: Week 52]

British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks [Time Frame: Baseline to Week 52]

Change From Baseline in C3 and C4 Complement Levels at Week 52 [Time Frame: Baseline to Week 52]

Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52 [Time Frame: Baseline to Week 52]

Secondary ID(s)

U2970g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/02/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00282347