A 2 year study to investigate belimumab in membranous nephropathy

• Conditions: Idiopathic Membranous Nephropathy (IMN); MedDRA version: 14.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-000242-38-IT
• Lead Sponsor: GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-11
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent. 2. Histological diagnosis: Have new clinical diagnosis of IMN, as verified by biopsy (either by light microscope with immuno-fluorescence, or by electron microscope) in the last 3 years (biopsy results should be available for independent evaluation). 3. Proteinuria: Have clinically active disease (nephrotic range proteinuria) for at least 3 months prior to screening and no improvement (<30% reduction), despite supportive therapy (which must include maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may include statins, diuretics, dietary salt restriction). 4. Female Subjects: A female subject is eligible to participate if she is not pregnant or nursing and at least one of the following conditions apply: a. Non-childbearing potential b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Non-Idiopathic MN or other condition affecting the kidney: If the diagnosis of MGN is secondary to other conditions, or the subject has renal impairment from a condition that is not MN. 2. Anti-PLA2R autoantibody: Patients known to be negative for anti-PLA2R autoantibody. 3. Severely reduced or deteriorating kidney function: An eGFR at screening < 40 mL/min/1.73m2 (as determined by 4 variable version MDRD equation) or kidney function not stable (as defined by > 15% decrease in eGFR in 3 months before screening). 4. Blood Pressure: Uncontrolled hypertension 5. Prior Therapy: Have received treatment with the following therapies at the times specified prior to Day 0:(please see protocol page 42 for further information) 6. Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. 7. Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. 8. Acute or chronic infection: Have required management of acute or chronic infections, please view section 5.2.2 of the protocol for further information. 9. Liver disease: Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 10. Other diseases/conditions: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to IMN which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. Please view section 5.2.2 of the protocol for further information. 11. Positive serology: Have a historically positive HIV test or test positive at screening for HIV. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs please view section 5.2.2 of the protocol for further information. 12. Liver function tests: AST and ALT =2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 13. Immunodeficiency: Have an IgA deficiency (IgA level < 10 mg/dL) or have IgG level <250 mg/dL and have previously received any non-glucocorticoid immunosuppression during the previous 6 months. 14. Laboratory test abnormalities: Have clinically significant abnormalities in screening laboratory assessments (not related to the disease), as judged by investigator. 15. Drug sensitivity / Anaphylaxis: History of sensitivity or intolerance to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies. 16. Suicidality: Subjects who have evidence of serious suicide risk 17. Substance abuse: Evidence of current drug or alcohol abuse or dependence. 18. Blood donation: Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified