Clinical Trials Logo
  1. Home
  2. Renal Transplant Rejection
  3. NCT03646344

Heme Arginate in Transplantation Study — HOT2  

Renal Transplant Rejection Clinical Trial

Official title:
Heme Arginate in Transplantation Study - a Multi-centre Blinded Parallel-group Randomised Trial of Heme Arginate Versus Placebo to Reduce Delayed Graft Function in Kidney Transplant Recipients

Clinical Trial Summary

Organ shortage for transplant has necessitated use of kidneys from older donors, increasing the chance that the kidney will not work immediately or for as long as expected. The investigators gave the drug heme arginate (HA) to 20 kidney transplant patients in the first 24 hours after transplant, and showed that it may reduce kidney injury and is safe. The investigators plan to conduct a large study recruiting 600 patients to determine whether HA treatment increases the number of kidney transplants that work immediately. If successful, HA may be introduced into clinical practice at the end of this study. Patients will be invited to take part in the study once listed for a kidney transplant. Further discussions will be had with them when admitted for transplant, and they will be offered the opportunity to participate. Consent will not be taken until the patient is admitted for transplantation. Following consent, participants will be randomised to receive either 2 doses of the study drug, HA, or a salt water solution, one at the time of transplant, and one approximately 24 hours later. Otherwise, treatment will be the same as any other patient undergoing a kidney transplant. Information about recovery from surgery, and specifically about kidney function, will be collected, but will not require additional blood tests. The study period ends after the first 7 days post-transplant, although longer term data will be collected from routine follow up appointments. Participants will be asked to complete a simple quality of life questionnaire 3 times: just before transplant, at approximately one week and three months after transplant.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03646344
Study type Interventional
Source University of Edinburgh
Contact
Status Terminated
Phase Phase 3
Start date March 12, 2019
Completion date February 23, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03140514 - Urine CXCL10 Chemokine Monitoring Post-renal Transplant N/A
Completed NCT02581436 - Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR N/A
Active, not recruiting NCT02409940 - To Elucidate the Effect of Mesenchymal Stem Cells on the T Cell Repertoire of the Kidney Transplant Patients Phase 1
Completed NCT02377193 - Simulect Versus ATG in Sensitized Renal Transplant Patient Phase 4
Completed NCT00771745 - Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients Phase 4
Not yet recruiting NCT05385432 - Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies Phase 3
Completed NCT01953120 - Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309) Phase 4
Terminated NCT01324934 - Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids Phase 3
Terminated NCT00983645 - A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity Phase 4
Active, not recruiting NCT04530630 - Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant Phase 4
Recruiting NCT03707262 - Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor Phase 1/Phase 2
Completed NCT02006108 - Imaging Kidney Transplant Rejection Using Ferumoxytol-Enhanced Magnetic Resonance N/A
Recruiting NCT03991780 - Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection Phase 1/Phase 2
Completed NCT02733029 - Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection Phase 2
Active, not recruiting NCT02057965 - Mesenchymal Stromal Cell Therapy in Renal Recipients Phase 2
Completed NCT00658073 - Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts N/A
Completed NCT02866682 - Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients Phase 4
Not yet recruiting NCT06438107 - Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes
Completed NCT02500251 - Belimumab Impacting Transplant Eligibility Phase 1/Phase 2
Completed NCT00866879 - Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients Phase 4