Kidney Transplant Recipients Clinical Trial
Official title:
A Two Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of the Combined Use of Once Daily 10mg Dapagliflozin and Once Weekly 1.0mg Semaglutide in Kidney Transplant Recipients
The study aims to determine the short-term efficacy, mechanisms and safety of 12 weeks of dapagliflozin and semaglutide combination therapy in 20 KTR, with and without T2D.
Kidney transplantation improves survival and quality of life for patients with kidney failure. However, treatment options to protect the heart and the kidney in transplant recipients are lacking. Sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RA) are novel anti-diabetic drugs which not only lower blood sugar, but also lower blood pressure in the kidney's individual filtering units and protect kidney function in the long term. It is unclear if the protective mechanisms of these drugs also occur in people with a kidney transplant. Several smaller studies have shown that SGLT2 inhibitors or GLP-1RA used alone are safe in people with kidney transplants. No studies have yet to look at the combined use of SGLT2 inhibitors and GLP-1RA in kidney transplant recipients (KTR). The purpose of the HALLMARK study is to determine the mechanisms and safety of the combination use of semaglutide, a GLP-1RA, and dapagliflozin, a SGLT2 inhibitor. To investigate this, 20 kidney transplant recipients with and without diabetes will be treated with both semaglutide or dapagliflozin for 12 weeks followed by a combination of semaglutide and dapagliflozin for 12 weeks. The study will measure salt and water removal as well as the effect on blood pressure, kidney function, heart function, liver stiffness as well as the safety of these agents. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01336296 -
Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
|
Phase 4 | |
Recruiting |
NCT01150487 -
Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients
|
N/A | |
Completed |
NCT00217100 -
A Multivitamin Comparison Study in Kidney Transplant Recipients.
|
Phase 3 | |
Active, not recruiting |
NCT00199667 -
Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
|
Phase 4 | |
Terminated |
NCT01517984 -
Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation
|
Phase 2 | |
Recruiting |
NCT04642833 -
Prostate Cancer in Renal Transplants Recipients
|
||
Not yet recruiting |
NCT05293704 -
An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients
|
Phase 4 | |
Completed |
NCT02555566 -
Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy - The TRANSPLANT-EETs Study
|
N/A | |
Completed |
NCT01782586 -
Validation of Gene Expression Markers of Renal Allograft Functional Decline
|
||
Enrolling by invitation |
NCT02042963 -
KoreaN Cohort Study for Outcome in Patients With Kidney Transplantation (KNOW-KT)
|
N/A | |
Not yet recruiting |
NCT05702398 -
Pilot Trial of Supplemental Vitamin A and Nicotinamide
|
Early Phase 1 | |
Active, not recruiting |
NCT05425498 -
The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
|
N/A | |
Completed |
NCT01889758 -
Pharmacokinetic Studies of Tacrolimus in Transplant Patients
|
Phase 4 | |
Terminated |
NCT02268201 -
A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
|
Phase 4 | |
Active, not recruiting |
NCT03979365 -
Envarsus XR Compared to Immediate Release Tacrolimus
|
Phase 4 | |
Recruiting |
NCT04965935 -
Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients
|
Phase 3 | |
Recruiting |
NCT04444843 -
Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen
|
Phase 4 | |
Completed |
NCT02392312 -
Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
|
||
Completed |
NCT02639949 -
Measuring and Improving Medication Adherence in Kidney Transplant Patients
|
N/A | |
Withdrawn |
NCT02058875 -
Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring
|
Phase 4 |