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Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes? (APOLLO)

Primary Purpose

Kidney Transplant Failure, Chronic Kidney Failure

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Normothermic machine perfusion
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplant Failure focused on measuring Normothermic kidney machine perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • kidney-only transplant
  • renal replacement therapy at time of transplant
  • receiving standard immunosuppression regimen post-transplant.
  • Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.

Exclusion Criteria:

  • pre-emptive at time of transplant
  • receive a multi-organ or dual kidney transplant
  • age donor or recipient below 18 years
  • Maastricht type I and II DCD
  • donor kidneys preserved on static cold storage (SCS)
  • kidneys retrieved after normothermic regional perfusion (NRP)
  • Recipient virtual panel reactive antibodies ≥85%
  • Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria

Sites / Locations

  • Erasmus MC Transplant InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Normothermic machine perfusion

Standard-of-care

Arm Description

Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate.

Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands.

Outcomes

Primary Outcome Measures

Number of patients with immediate graft function
Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.

Secondary Outcome Measures

Duration of delayed graft function
estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant
Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant
all-cause and death-censored graft survival up to 5 years
patient survival up to 5 years

Full Information

First Posted
May 6, 2021
Last Updated
July 19, 2021
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04882254
Brief Title
Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?
Acronym
APOLLO
Official Title
Normothermic Machine Perfusion as Additional Value to Hypothermic Machine Perfusion for Kidney Transplant Outcomes. A Single-centre, Open-label, Randomised, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant Failure, Chronic Kidney Failure
Keywords
Normothermic kidney machine perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normothermic machine perfusion
Arm Type
Experimental
Arm Description
Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate.
Arm Title
Standard-of-care
Arm Type
No Intervention
Arm Description
Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands.
Intervention Type
Procedure
Intervention Name(s)
Normothermic machine perfusion
Intervention Description
Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.
Primary Outcome Measure Information:
Title
Number of patients with immediate graft function
Description
Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Duration of delayed graft function
Time Frame
3 months
Title
estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant
Time Frame
1 year
Title
Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant
Time Frame
1 year
Title
all-cause and death-censored graft survival up to 5 years
Time Frame
5 years
Title
patient survival up to 5 years
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: kidney-only transplant renal replacement therapy at time of transplant receiving standard immunosuppression regimen post-transplant. Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys. Exclusion Criteria: pre-emptive at time of transplant receive a multi-organ or dual kidney transplant age donor or recipient below 18 years Maastricht type I and II DCD donor kidneys preserved on static cold storage (SCS) kidneys retrieved after normothermic regional perfusion (NRP) Recipient virtual panel reactive antibodies ≥85% Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria
Facility Information:
Facility Name
Erasmus MC Transplant Institute
City
Rotterdam
ZIP/Postal Code
3015GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Minnee, MD, PhD
Phone
+31107031149
Email
r.minnee@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34708171
Citation
Rijkse E, Bouari S, Kimenai HJAN, de Jonge J, de Bruin RWF, Slagter JS, van den Hoogen MWF, IJzermans JNM, Hoogduijn MJ, Minnee RC. Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial. Int J Surg Protoc. 2021 Oct 6;25(1):227-237. doi: 10.29337/ijsp.165. eCollection 2021.
Results Reference
derived

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Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?

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