Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04882254
Other study ID # APOLLO
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 1, 2021
Est. completion date May 2025

Study information

Verified date May 2024
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date May 2025
Est. primary completion date May 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Normothermic machine perfusion
Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.

Locations

Country Name City State
Netherlands Erasmus MC Transplant Institute Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary Duration of delayed graft function 3 months
Secondary estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant 1 year
Secondary Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant 1 year
Secondary all-cause and death-censored graft survival up to 5 years 5 years
Secondary patient survival up to 5 years 5 years
See also
  Status Clinical Trial Phase
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT00806130 - Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
Completed NCT00781690 - Reduction of Heparin Dose in Dialysis With Evodial System N/A
Completed NCT00153621 - Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients N/A
Completed NCT06165211 - Nature-Based Sound Application For Hemodialysis Patients N/A
Not yet recruiting NCT04013620 - CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction Phase 3
Withdrawn NCT03998917 - Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
Completed NCT02586376 - Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF) N/A
Completed NCT00794326 - Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD Phase 3
Completed NCT05185999 - Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients Phase 1
Completed NCT03076528 - An Innovative Virtually Supervised Exercise for Dialysis Patients Phase 2
Completed NCT02513303 - Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes Phase 3
Completed NCT00804453 - Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line N/A
Unknown status NCT00788905 - Comparison of Conventional Dialysis and the Allient System N/A
Completed NCT01085552 - Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects Phase 1
Completed NCT00694824 - Vascular Calcification's Risk Factors in Haemodialysis Patients
Completed NCT00074620 - A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis Phase 2
Withdrawn NCT06030050 - Animal Assisted Intervention for Hemodialysis Outpatients N/A
Recruiting NCT05562869 - Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction Phase 3
Completed NCT03437538 - Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter N/A