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Renal Transplantation clinical trials

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NCT ID: NCT06406179 Not yet recruiting - Clinical trials for Renal Transplantation

Assesment the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"

AI-CARE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The investigator hypothesizes that the combined use of (1) Donor-derived cell-free DNA (dd-cfDNA) in peripheral blood predicting anti-donor immunological activation or quiescence (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive biopsy and less induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients. In addition, the evaluation of the transcriptional changes in tissue samples in selected patients using automated processing of digital slide images and intragraft gene expression profiles will provide a better diagnosis of the rejection mechanisms to provide the best therapeutic approach as compared to current clinical practice. We therefore propose a French, multicenter, prospective randomized trial comparing two strategies of follow-up: in the first group, a biopsy is performed at M3, M12 and for clinical indication whenever considered necessary by the clinician during the first 18 months of follow-up after transplant. In the second group, biopsies are guided by dd-cfDNA at the same timepoints

NCT ID: NCT06150287 Not yet recruiting - Clinical trials for Renal Transplantation

Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients

Start date: December 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. The main questions it aims to answer are: 1. Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea? 2. Does probiotics effective in reducing inflammation? 3. Is there any connection between fecal microbiome and immunological markers? Participants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. Researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.

NCT ID: NCT06026592 Not yet recruiting - Acute Kidney Injury Clinical Trials

Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients

DART-REIN
Start date: September 30, 2023
Phase:
Study type: Observational

Donor-derived cell-free DNA (dd-cfDNA) has been proposed as a potential diagnostic tool to monitor the rejection status of the kidney transplant. It has been suggested that dd-cfDNA is increasing in the blood of kidney transplant patient presenting a graft rejection. In this project, investigators proposed a different approach to predict and characterize kidney transplant rejection/dysfunction based on the quantification of epigenetic signatures present on the donor-cell-free DNA. In 2018, Moss et al. develops a deconvolution model capable of identifying the tissue origin of circulating DNA by taking advantage of its epigenetic properties. The study confirmed that the cell-free DNA circulating in healthy subjects comes mainly from blood cells and endothelial cells, but not from kidney cells. In this study, researchers investigate the evolution of blood renal-specific cell-free DNA amount in patient with chronic kidney disease before and after the transplantation surgery by testing a set of renal-specific epigenetic markers. The purpose of this study is to identify the biological noise of "native kidney" on renal-specific cell-free DNA and to compare it with signal coming from "transplanted kidney".

NCT ID: NCT05935293 Not yet recruiting - Dexmedetomidine Clinical Trials

Dexmedetomidine and Kidney Transplantation

DexTR
Start date: December 1, 2024
Phase: Phase 4
Study type: Interventional

Dexmedetomidine, an alpha 2 agonist, is being increasingly used in recent years for the maintaining of anesthesia as it allows sedation and analgesia with only a modest respiratory depression effect when compared to opioids and inhaled anesthetic agents and allows maintenance of spontaneous ventilation. Most common side effects are bradycardia and hypotension. Drug's metabolism is exclusively hepatic and therefor do not require dosage adaptation for patient's kidney function. Post-Operative acute kidney injury (AKI) is a common complication after major surgery and might incur serious adverse outcomes such as longer hospital stay, dialysis, chronic kidney disease and death. The most common theory for the occurrence of post-operative AKI is the ischemic-reperfusion syndrome. Several in vitro animal studies as well as human studies have suggested the nephroprotective effects of per-operative continuous infusion of dexmedetomidine and its ability to decrease post-operative AKI. Kidney transplantation (KT) is the treatment of choice for patients with End Stage Renal Disease. It is considered a major surgery and it was shown that optimized perioperative management could improve post-operative outcomes such as early graft function as measured by urine output and serum creatinine trends. However, delayed graft function (DGF), which is defined by the need for dialysis within the first seven days after transplantation remains a significant issue for post-operative KT care with an incidence of up to 30%. A retrospective study of 780 patients receiving KT, has shown that preoperative dexmedetomidine could significantly decrease occurrence of DGF. Recently, two single-center, randomized controlled trials, with similar sample sizes of 104 and 111 patients, compared peri-operative continuous infusion of dexmedetomidine to placebo. One study failed to show significant impact on DGF incidence while the second showed a significant 50% reduction in DGF in the dexmedetomidine group. Due to increasing evidence concerning the nephroprotective effects and improved post-operative outcomes of perioperative continuous dexmedetomidine infusion, a larger, multi-center randomized-controlled trial to study and potentially confirm the evidence in the settings of KT would be of benefit. The aim of our study is to assess whether the perioperative continuous infusion of dexmedetomidine during KT could improve peri-operative renal function among KT recipients as compared to placebo.

NCT ID: NCT05833750 Completed - Fatigue Clinical Trials

Effects of Reflexology in Transplant Patients

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Abstract Objective: The aim of this study is to examine the effect of reflexology on fatigue in kidney transplant patients. Design: The study will be conducted as randomized, controlled and experimental. Method: The data of the research will be collected in the transplant clinic of a foundation university practice and research hospital between 07.12.2020 - 18.06.2021. While the population of the study consisted of 254 patients who underwent kidney transplantation in the transplant unit, 68 patients were included in the sample. The patients included in the study were divided into reflexology (n=34) and control (n=34) groups with the help of a program. Data will be collected using Questionnaire and Piper Fatigue Scale. Chi-square test, Student's t test, Mann Whitney U test and Kruskal-Wallis test, correlation, generalized estimation equation and Least Significant Difference tests will be used in the evaluation of the data. Keywords: kidney transplantation, reflexology, fatigue, nursing.

NCT ID: NCT05669001 Recruiting - Clinical trials for Renal Transplantation

A Study of TCD601 in de Novo Renal Transplant Recipients

ASCEND
Start date: December 28, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.

NCT ID: NCT05240274 Completed - Clinical trials for End Stage Renal Disease

The POWERED Study: Prophylaxis With Metformin to Prevent PTDM

POWERED
Start date: January 25, 2019
Phase: Phase 2
Study type: Interventional

PrOphylaxis With mEtformin to pREvent PTDM: a single site, placebo controlled, double blind randomised clinical trial evaluating the effectiveness of metformin to prevent post-transplant diabetes in a cohort of patients undergoing renal transplantation.

NCT ID: NCT05208788 Completed - Clinical trials for Renal Transplantation

Urinary Biomarkers in Paediatric Kidney Transplantation (pKTx)

Start date: June 1, 2021
Phase:
Study type: Observational

This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may be observed after event-specific injury, (3) differences between paediatric renal transplant patients with AR and other causes of AKI can be detected, and (4) stratification of renal transplant patients to different histological types of AR is possible.

NCT ID: NCT05086003 Recruiting - Clinical trials for Renal Transplantation

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Start date: January 19, 2016
Phase: Phase 2
Study type: Interventional

Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.

NCT ID: NCT04863716 Completed - Clinical trials for Renal Transplantation

Erector Spinae Plane Block in Renal Transplantation Donors

Start date: April 28, 2021
Phase: N/A
Study type: Interventional

Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. Studies showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery are limited to case reports. In this study, the effect of Erector Spina Plan Block on opioid consumption in postoperative period on donor patients who will undergo laparoscopic nephrectomy in renal transplantation surgery will be examined prospectively. The aim of the study is to provide analgesia to donor patients using less opioids by Erector Spina Plan Block and provide enhanced recovery.