Belatacept for Renal Transplant Recipients With Delayed Graft Function

Delayed Graft Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02134288
• Other study ID #: IM103-336
• Secondary ID: 2013H0312
• Status: Terminated
• Phase: Early Phase 1
• Start date: April 2014
• Est. completion date: January 18, 2019

Study information

• Verified date: September 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 18, 2019
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Graft Function

Intervention

Drug:
• Belatacept

• Everolimus

Locations

Country	Name	City	State
United States	The Ohio State Universtiy Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent patients reaching recovery (defined above) by 14 days and 3 months.	Percent patients reaching recovery (defined above) by 14 days and 3 months.	Assessed at 3, 6, 12 months
Secondary	Hospital length of stay (days) from date of transplant to discharge	by monitoring patient while inpatient	up to 7 days
Secondary	Number of dialysis treatments	by monitoring patients health at each visit, and notification of hospitalizations/AE's	Assessed at 3, 6, 12 months
Secondary	Number of biopsies	medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period	Assessed at 3, 6, 12 months
Secondary	Biopsy proven acute rejection events	by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's	Assessed at 3, 6, 12 months
Secondary	Patient and graft survival	by monitoring patients health at each visit, and notification of hospitalizations/AE's	Assessed at 3, 6, 12 months
Secondary	Number of hospital readmissions	by monitoring patients health at each visit, and notification of hospitalizations/AE's	Assessed at 3, 6, 12 months
Secondary	Detection of DSA (Luminex)	by blood draw	Assessed at 3, 6, 12 months
Secondary	Incidence and type of infection	by monitoring patients health at each visit, and notification of hospitalizations/AE's	Assessed at 3, 6, 12 months
Secondary	Measured or estimated creatinine clearance.	by blood draw	Assessed at 3, 6, 12 months
Secondary	Banff score of rejection episodes and immune suppression treatment/management of rejection	by monitoring patients health at each visit, and notification of hospitalizations/AE's	Assessed at 3, 6, 12 months
Secondary	Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).	by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's	Assessed at 3, 6, 12 months