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Trial record 1 of 1 for:    NCT02592798
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Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

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ClinicalTrials.gov Identifier: NCT02592798
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Focal Segmental Glomerulosclerosis Minimal Change Disease Drug: Abatacept Other: Normal Saline Other: D5W Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : January 28, 2020


Arm Intervention/treatment
Experimental: Abatacept

Abatacept intravenous injection every 28 days

Adults will use the weight-tiered dose: < 60 kg: 500 mg, 60 to 100 kg: 750 mg, > 100 kg: 1000 mg

Pediatric patients 6 to 17 years who weigh < 75 kg will receive:10 mg/kg

Drug: Abatacept
Placebo
Normal saline or D5W (5% Dextrose in Water)
Other: Normal Saline
Other: D5W
Other Name: 5% Dextrose in Water




Primary Outcome Measures :
  1. Proportion of subjects in Renal Response at Day 113 [ Time Frame: 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 Outcome Measures :
  1. Mean change from baseline in Urine Protein to Creatinine Ratio (UPCR) at Day 113 [ Time Frame: Day 113 ]
  2. Mean change from baseline in serum albumin at Day 113 [ Time Frame: Day 113 ]
  3. Proportion of subjects achieving complete remission [ Time Frame: Day 113 ]
    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

  4. Mean change in PROMIS measures [ Time Frame: Day 113 ]
    Patient Reported Outcomes Measurement Information System (PROMIS)

  5. Safety measured by incidence, potential significance and clinical importance of AEs, SAEs, as determined by medical review of AE reports, vital sign measurements and results of physical examination and laboratory tests [ Time Frame: 16 months ]
    Adverse Event (AE), Serious adverse event (SAE)

  6. Proportion of subjects with positive antibody response relative to baseline over time [ Time Frame: 16 months ]


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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 ≥ 45 for children and adults
  • Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks or have intolerance documented in the source documents maintained at the site

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
  • Post renal transplantation, including relapsing post-transplant FSGS
  • Body mass index (BMI): > 40 in subjects ≥ 18 years of age and ≥ 99% percentile for subjects < 18 years of age

Other protocol defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592798


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02592798    
Other Study ID Numbers: IM101-566
2015-005450-36 ( EudraCT Number )
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Glomerulosclerosis, Focal Segmental
Nephrosis, Lipoid
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Nephritis
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents