A randomized, double blind, placebo-controlled, three arm, parallel group, multicenter, multinational safety and efficacy trial of 300 mg and 900 mg of abetimus sodium in systemic lupus erythematosus (sle) patients with a history of renal disease

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2008/006
• Date of registration: 28/03/2008
• Primary sponsor: La Jolla Pharmaceutical Company
• Public title: A randomized, double blind, placebo-controlled, three arm, parallel group, multicenter, multinational safety and efficacy trial of 300 mg and 900 mg of abetimus sodium in systemic lupus erythematosus (sle) patients with a history of renal disease
• Scientific title: A randomized, double blind, placebo-controlled, three arm, parallel group, multicenter, multinational safety and efficacy trial of 300 mg and 900 mg of abetimus sodium in systemic lupus erythematosus (sle) patients with a history of renal disease
• Date of first enrolment: 7/4/2008
• Target sample size: 740 patients
• Recruitment status: Recruiting
• URL: http://www.slctr.lk/trial_details.asp?reg_id={BD9D34FA-F0B0-486D-9D87-BE84C6074797}
• Study type: Interventional
• Study design: Double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational trial

Countries of recruitment

Czech republic, Hong Kong, Hungary, Korea, Mexico, Poland, Singapore, Slovak Republic, Taiwan, Argentina, Philipines, Thailand, Malaysia, Indoesia, Germany, Brazil, South Africa, Belaraus, Georgia, United Kingdom, United States, India

Contacts

• Name: Dr Priyadarshani Galappatthy
• Affiliation: Senior Lecturer and Specialist Physician

• Name: Dr Priyadarshani Galappatthy
• Affiliation: Senior Lecturer and Specialist Physician

Key inclusion & exclusion criteria

Inclusion criteria: Males or females between 12 and 70 years old, inclusive Female patients must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrollment in the study. Female patients of childbearing potential (including peri menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate of less than 1% per year, when used consistently and correctly, for example oral contraceptives, contraceptive patch, implants, injectables, some intrauterine contraceptive devices [IUDs], or sexual abstinence) during the entire duration of the study. Males enrolled in the trial must have no plans to father a child during the course of the trial and agree to use adequate birth control methods Diagnosis of SLE for purposes of this trial utilize the 1996 Revised Criteria for the Classification of SLE as defined by the American College of Rheumatology (ACR) where a diagnosis of SLE is established when = 4 of the 11 criteria are met
1. At least one documented episode of active SLE renal disease within 4 years prior to randomization at study Visit 3
2. Elevated anti-dsDNA antibody concentration at pre-screening Visit 0 (= 10 IU/mL) as measured by the Farr assay at the regional central laboratory
3. Ability to communicate meaningfully with the investigational staff, competence to give written informed consent, and ability to comply with the entire study procedure
4. Duly executed, written, informed consent obtained from the patient, next of kin, or other legal representative
Exclusion criteria: Active SLE renal disease in the 3 months prior to Visit 3
An increase in the anti-ds DNA antibody concentration of more than 50% with an incremental increase of at least 50 units in anti-dsDNA antibody concentration by Farr assay between the samples taken at Visit 0 and Visit 1 during the screening period
Use of the following therapeutics:
Prednisone > 20 mg/day within 1 month prior to Visit 1 ,Any use of the following within 2 months prior to randomization or 1 month prior to Visit 1: alkylating agents (e.g., cyclophosphamide) TNF inhibitors (e.g., etanercept, infliximab) cyclosporine plasmapheresis intravenous immunoglobulin,prosorba column Any use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds100 mg/day, methotrexate that exceeds 10 mg/week , leflunomide that exceeds 10 mg/day , rituximab within 5 months Previous or concurrent medications and other therapies or devices that in the judgement of the Investigator are likely to confound the evaluation of the safety or efficacy of abetimus sodium
Patient has received any investigational new drug ordevice within 30 days prior to screening or 5 half-lives of the agent (whichever is longer), or any investigational new drug with a long-term effect
Prior participation in study LJP 394-90-14
Exclusionary laboratory values: leukocyte count less than 2,000 cells/mm3 , platelet count less than 50,000 cells/mm3, hemoglobin less than 8.5 gm/dL , serum hepatic transaminases = 3X the upper limit of normal, serum creatinine > 3.5 mg/dL within the 2 months prior to randomization
Malignant disease or immunodeficiency syndrome within 5 years, excepting patients with basal cell or squamous cell carcinoma of the skin with complete excision and clean borders
Evidence of current abuse of drugs or alcohol
History of poor procedural compliance in previous investigational studies
History of serious cardiac disease or functional classification New York Heart Association Class III or IV
Patient has previously undergone organ transplantation 10 Other medical conditions, including but not limited to diabetic nephropathy, uncontrolled hypertension, history of patient being HIV positive, that are considered by the Investigator to preclude adequate evaluation of drug safety or efficacy.
11 Patient has known hypersensitivity to the class of medications under study or any of the constituents of abetimus sodium.
12 Patients who have any other acute or chronic disease which in the opinion of the Investigator that may influence the outcome of the study may also be excluded

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Weekly intravenous administration of 300 or 900 mg abetimus sodium or placebo for 52 weeks in patients with a history of SLE renal disease

Primary Outcome(s)

The primary objective of this trial is to determine whether abetimus sodium is more effective than place in delaying the time to renal flare in SLE patients with a history of SLE renal disease. The safety and efficacy of abetimus sodium in SLE patients will be evaluated at weekly doses of 300 and 900 mg over than intended 52-week exposure period

Secondary Outcome(s)

The secondary objectives of the trial are to determine whether treatment with abetimus sodium is more effective than placebo in reducing proteinuria and in delaying time to all major SLE flares

Secondary ID(s)

NCT00089804 (clinicaltrials.gov)

Source(s) of Monetary Support

La Jolla Pharmaceutical Company, San Diego, California, USA