NCT02134288

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Apr 2014

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

4.7 years

First QC Date

April 21, 2014

Last Update Submit

September 17, 2021

Conditions

Delayed Graft Function

Keywords

DialysisKidney Transplantimmunosuppressive therapyDelayed Graft FunctionBelatacept

Outcome Measures

Primary Outcomes (1)

  • Time to recover from Delayed Graft Function

    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 Outcomes (12)

  • 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

    up to 7 days

  • Number of dialysis treatments

    Assessed at 3, 6, 12 months

  • Number of biopsies

    Assessed at 3, 6, 12 months

  • Biopsy proven acute rejection events

    Assessed at 3, 6, 12 months

  • +7 more secondary outcomes

Study Arms (2)

Belatacept

ACTIVE COMPARATOR

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

Everolimus

ACTIVE COMPARATOR

Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.

Drug: Everolimus

Interventions

BelataceptDRUG
Also known as: NULOJIX
Belatacept
EverolimusDRUG
Also known as: zortress
Everolimus

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Seronegative or unknown EBV serostatus
  • Patients unwilling or incapable of providing informed consent.
  • Patients with active tuberculosis or positive TB test without evidence of infection treatment.
  • 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
  • Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
  • Inadequate vein access to receive monthly IV infusions
  • Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
  • Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
  • 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.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  • Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State Universtiy Wexner Medical Center

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Delayed Graft Function

Interventions

AbataceptEverolimus

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsSirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Jon Von Visger, M.D./Ph.D.

    OSU Wexner Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

May 9, 2014

Study Start

April 1, 2014

Primary Completion

December 11, 2018

Study Completion

January 18, 2019

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)