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Kidney Transplantation clinical trials

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NCT ID: NCT06186843 Recruiting - Hypertension Clinical Trials

Plant-based Diet for Kidney Transplant Recipients

Start date: February 29, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate cardiometabolic and inflammatory parameters in kidney transplant recipients after transitioning to a plant-based diet (PBD). The main aims of the study are as follows: - To test the feasibility of transiting renal allograft recipients who are > 3 months post-transplant to a PBD - To study the effect of a PBD on cardiometabolic parameters in kidney transplant recipients - To assess the effect of a PBD on peripheral blood Th17/Treg ratio and systemic inflammation in kidney transplant recipients Participants will be asked to: - Complete a 2-week investigator-designed PBD transition program - Follow a PBD for a minimum of 16 weeks - Consent for blood draws, urine samples, and fecal samples along with physical exams - Complete intermittent food frequency questionnaires and quality of life questionnaires - Periodically meet with investigators and other study participants Researchers will compare baseline measurements with future measurements for each participant.

NCT ID: NCT06148116 Recruiting - Kidney Transplant Clinical Trials

Attitudes and Knowledge of Dialysis Patients Towards Kidney Transplantation

Start date: July 1, 2023
Phase:
Study type: Observational

In Poland, approximately 4.2 million people suffer from chronic kidney disease [1]. In December 2022, a total of 20,198 patients were dialyzed in the country, of which 96% by hemodialysis (HD) and 4% by peritoneal dialysis (DO). In 2022, kidney transplantation was performed in 2.6% of patients dialyzed using the HD method and in 15.4% of patients dialyzed using the DO method [2]. According to the data of the Organizational and Coordination Center for Transplantation "Poltransplant", in 2022 on the national waiting list 1,119 people were registered for kidney transplantation. The average age of those waiting was 49 years [3]. In Poland, according to data from 2022, the average waiting time for transplantation in the case of the first transplant from the moment of registration on the waiting list was 387 days, and 1,106 days from the start of dialysis. Data show that only 5.5% of patients undergoing renal replacement therapy are on the waiting list [3]. Therefore, a study was designed to examine the knowledge and attitudes towards kidney transplantation among dialysis patients. The study will include a representative group of dialysis patients from all voivodeships and aims to identify positive and negative aspects related to patients' attitudes towards kidney transplantation. The scientific value of the study is worth emphasizing, because so far in Poland no research has been conducted on the knowledge and attitudes towards kidney transplantation among dialysis patients in all voivodeships in the country. The study will identify the level of knowledge and attitudes of dialysis patients towards transplantation. The results of this study may contribute to the development and implementation of new educational and information programs that may increase the level of knowledge and influence attitudes towards transplantation, which may largely contribute to the increase in transplantation among people with chronic kidney disease. References: 1. Gellert R, Durlik M, Małgorzewicz S. Raport 2019. Ogólnopolskie Badanie Pacjentów Nefrologicznych. Forum Nefrologiczne. 2020;13(3):149-63. 2. Dębska-Ślizień A, Rutkowski B, Rutkowski P et al. (2022). Aktualny stan leczenia nerkozastępczego w Polsce-2022. Nefrol Dializoter Pol, 26: 21-38. 3. Centrum Organizacyjno- Koordynacyjne do spraw transplantacji-Poltransplant. Biuletyn Informacyjny 2023. https://files.poltransplant.org.pl/Biuletyn_2023_www.pdf Accessed 13 November 2023.

NCT ID: NCT06147076 Recruiting - Kidney Transplant Clinical Trials

Social Support Counseling Intervention for Kidney Transplant Candidates

JtT
Start date: March 2024
Phase: N/A
Study type: Interventional

Virtual Coaching for Potential Kidney Transplant Patients

NCT ID: NCT06140537 Recruiting - Diabetes Clinical Trials

Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.

NCT ID: NCT06130046 Recruiting - Clinical trials for Kidney Transplant; Complications

MR-proADM as a Early Biomarker for DGF and AR in Kidney and Liver Transplantation

DARE
Start date: December 1, 2022
Phase:
Study type: Observational

To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation creating a predictive model for related complications after kidney and liver transplantation based on the pre-operative and post-operative levels of MR-proADM and by a machine learning process.

NCT ID: NCT06104696 Recruiting - Clinical trials for Kidney Transplant; Complications

Comprehensive Geriatric Assessment in Kidney Transplantation

CoGeriaTx
Start date: January 2, 2020
Phase:
Study type: Observational

This observational study aims to analyze the results of comprehensive geriatric assessment and to monitor the development of functional status in geriatric kidney transplant candidates and recipients.

NCT ID: NCT06100965 Recruiting - Clinical trials for Kidney Transplant Rejection

Reduced-dose Alemtuzumab for Kidney Transplant Rejection

ROSETTE
Start date: December 1, 2023
Phase:
Study type: Observational

Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.

NCT ID: NCT06095492 Recruiting - Diabetes Mellitus Clinical Trials

Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus

EmLinaRenal
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

In the early postoperative period, hyperglycemia is frequently seen in renal transplant recipients primarily because of high doses of immunosuppressive therapy. Many of these patients have pre-existing type 2 diabetes (T2D). However, 10-20% of renal transplant recipients develop new onset persisting hyperglycemia following renal transplantation, known as posttransplant diabetes mellitus (PTDM). These patients need optimal glycemic control in order to prevent development of cardiovascular and de novo renal disease. Most of these patients receive insulin therapy following transplantation, as they receive steroid therapy and oral hypoglycemic agents are better avoided. However, as steroids are tapered and need for insulin diminishes, several anti-diabetic agents are initiated off-label, such as metformin, DDP-4 inhibitors and sulfonylureas. Sodium-glucose cotransporter-2 (SGLT2) inhibitors exhibit nephroprotective effects in individuals with native kidney disease, with or without type 2 diabetes. However, the data regarding the safety and glycemic efficacy of these glucose-lowering agents in the renal transplant setting are scarce. DPP-4 inhibitors are glucose-lowering agents used in patients with CKD. For instance, linagliptin is used in all eGFRs without dose modification. The data regarding the safety and efficacy of linagliptin are scarce in patients following renal transplantation. Since patients following renal transplantation receive immunosuppressants and steroids, which may affect their body composition. Effect of SGLT2 inhibitors or DPP-4 inhibitors on body composition in patients following renal transplantation is not well established. In this study, we aimed to examine the safety and effect of empagliflozin (an SGLT2 inhibitor) versus linagliptin (an DDP-4 inhibitor) on the glycemic outcomes, renal outcomes and body composition in renal transplant recipients with diabetes mellitus.

NCT ID: NCT06059664 Recruiting - Clinical trials for Kidney Transplant; Complications

The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

EFFEKTOR is a vanguard, multicenter, phase 2 randomized, double blinded, placebo controlled clinical trial to determine the feasibility, tolerability, safety, and efficacy of finerenone in kidney transplant recipients (KTRs). One hundred fifty (150) KTRs will be randomized in a 2:1 ratio of finerenone to placebo, with two embedded substudies: (i) a kidney biopsy substudy in 50 participants who undergo a research kidney biopsy prior to randomization and at the end of active treatment; and (ii) a functional MRI (fMRI) substudy in 50 participants who undergo fMRI prior to randomization and at the end of active treatment.

NCT ID: NCT06056518 Recruiting - Clinical trials for Kidney Transplant Failure

Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care

PRIMA-AI
Start date: January 19, 2024
Phase: N/A
Study type: Interventional

This study aims to analyze the effects of AI-based risk prediction for graft loss on the frequency of conversations about the treatment after graft loss, as well as the associated shared decision making process in post-kidney transplant care in a German kidney transplant center (KTC), as perceived by the patient, their support person and the clinician/physician. Second, it aims to explore changes in patient and support person recall at 12 and 24 months follow-up. Implementation barriers and enablers will also be assessed.