Belatacept for Renal Transplant Recipients With Delayed Graft Function

September 17, 2021 updated by: Ohio State University

Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function

Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43212
        • The Ohio State Universtiy Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed Written Informed Consent
  2. Deceased donor renal transplant recipient
  3. Men and women, aged 18-60 years of age

Exclusion Criteria:

  1. Seronegative or unknown EBV serostatus
  2. Patients unwilling or incapable of providing informed consent.
  3. Patients with active tuberculosis or positive TB test without evidence of infection treatment.
  4. Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment
  5. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
  6. Inadequate vein access to receive monthly IV infusions
  7. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
  8. Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
  9. Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©) are not permitted in this protocol; Use of other immunosuppressive agents must be limited to those specified in this protocol.
  10. Prisoners or subjects who are involuntarily incarcerated.
  11. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  12. Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Belatacept
Belatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study.
Drug: Belatacept
Other Names:
  • NULOJIX
Active Comparator: Everolimus
Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.
Drug: Everolimus
Other Names:
  • zortress

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to recover from Delayed Graft Function
Time Frame: 2 weeks
For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks).
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Time Frame: Assessed at 3, 6, 12 months
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Assessed at 3, 6, 12 months
Hospital length of stay (days) from date of transplant to discharge
Time Frame: up to 7 days
by monitoring patient while inpatient
up to 7 days
Number of dialysis treatments
Time Frame: Assessed at 3, 6, 12 months
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Assessed at 3, 6, 12 months
Number of biopsies
Time Frame: Assessed at 3, 6, 12 months
medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period
Assessed at 3, 6, 12 months
Biopsy proven acute rejection events
Time Frame: Assessed at 3, 6, 12 months
by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Assessed at 3, 6, 12 months
Patient and graft survival
Time Frame: Assessed at 3, 6, 12 months
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Assessed at 3, 6, 12 months
Number of hospital readmissions
Time Frame: Assessed at 3, 6, 12 months
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Assessed at 3, 6, 12 months
Detection of DSA (Luminex)
Time Frame: Assessed at 3, 6, 12 months
by blood draw
Assessed at 3, 6, 12 months
Incidence and type of infection
Time Frame: Assessed at 3, 6, 12 months
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Assessed at 3, 6, 12 months
Measured or estimated creatinine clearance.
Time Frame: Assessed at 3, 6, 12 months
by blood draw
Assessed at 3, 6, 12 months
Banff score of rejection episodes and immune suppression treatment/management of rejection
Time Frame: Assessed at 3, 6, 12 months
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Assessed at 3, 6, 12 months
Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).
Time Frame: Assessed at 3, 6, 12 months
by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Assessed at 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jon Von Visger, M.D./Ph.D., OSU Wexner Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM103-336
  • 2013H0312 (Other Identifier: The Ohio State University Wexner Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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