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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 8 August 2016
Main ID:  EUCTR2015-005450-36-Outside-EU/EEA
Date of registration: 01/08/2016
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb Company
Public title: Pilot to Evaluate the Safety and Efficacy of Abatacept in Adults and Children Over the Age of 6 With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
Scientific title: A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms With Switchover, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change)
Date of first enrolment:
Target sample size: 100
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005450-36
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
United States
Contacts
Name: CTT group Manager   
Address:  Route 206 and Province Line Road NJ 08543 Lawrenceville United States
Telephone:
Email: ctt.group@bms.com
Affiliation:  Bristol-Myers Squibb Company
Name: CTT group Manager   
Address:  Route 206 and Province Line Road NJ 08543 Lawrenceville United States
Telephone:
Email: ctt.group@bms.com
Affiliation:  Bristol-Myers Squibb Company
Key inclusion & exclusion criteria
Inclusion criteria:
• Male and female subjects ages = 6 years
• Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these
• UPCR = 3 at screening
• FSGS or MCD confirmed by renal biopsy
• eGFR = 60 for children and = 45 for adults
• Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks
Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion criteria:
• Kidney diseases other than FSGS or MCD
• Collapsing FSGS
• Systemic lupus erythematosus
• Diabetes mellitus, both type 1 and type 2
• Clinically significant congestive heart failure
• Body mass index (BMI): > 40 in subjects = 18 years of age and = 99% percentile for subjects < 18 years of age


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: Demonstrate improvement in nephrotic range proteinuria to sub-nephrotic range while
maintaining renal function following treatment with abatacept compared to placebo.
Primary end point(s): Proportion of subjects in Renal Response at Day 113.
Proportion of subjects in Renal Response (reduction in baseline UPCR of = 50% and to less than 3 with no worsening of baseline estimated glomerular filtration rate (eGFR: normal or = 75% baseline if below normal at baseline)
Secondary Objective: 1) Assess improvement in change from baseline in the level of proteinuria following treatment with abatacept compared to placebo.
2) Assess improvement in serum albumin levels following treatment with abatacept compared to placebo.
3) Assess improvement in complete remission while maintaining renal function following treatment with abatacept compared to placebo.
4) Assess improvement in patient reported outcomes related to nephrotic syndrome.
5) Assess the safety and immunogenicity of abatacept in subjects with TRNS.
6) Assess the pharmacokinetics of abatacept in subjects with TRNS
Timepoint(s) of evaluation of this end point: Day 113
Secondary Outcome(s)
Secondary end point(s): • Mean change from baseline in Urine Protein to Creatinine Ratio (UPCR) at Day 113
• Mean change from baseline in serum albumin at Day 113
• Proportion of subjects achieving complete remission, Proportion of subjects achieving complete remission (UPCR = 0.3 with Estimated glomerular filtration rate (eGFR): normal or = 75% baseline if below normal at baseline) at Day 113
• Mean change in PROMIS measures, Patient Reported Outcomes Measurement Information System (PROMIS)
• Safety measured by incidence, potential significance and clinical importance of AEs, SAEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical
examination and laboratory tests. Adverse Event (AE), Serious adverse event (SAE)
• Proportion of subjects with positive antibody response relative to baseline over time
Timepoint(s) of evaluation of this end point: Day 113
Secondary ID(s)
IM101-566
NCT02592798
Source(s) of Monetary Support
Bristol-Myers Squibb Company
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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