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Kidney Transplantation clinical trials

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NCT ID: NCT02711826 Completed - Kidney Transplant Clinical Trials

Treg Therapy in Subclinical Inflammation in Kidney Transplantation

TASK
Start date: September 20, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is: - To see if polyTregs can reduce inflammation in a transplanted kidney. - To find out what effects, good or bad, polyTregs will have in the kidney recipient. - To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.

NCT ID: NCT02711202 Completed - Clinical trials for Kidney Transplantation

Sequential Targeting of Cluster of Differentiation 52 (CD52) and Tumor Necrosis Factor (TNF) Allows Early Minimization Therapy in Kidney Transplantation

Start date: January 2007
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.

NCT ID: NCT02705573 Completed - Clinical trials for Kidney Transplantation, Mannitol

Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

In this study we want to evaluate the effect of mannitol on postoperative renal biomarkers in patient receiving cadaveric renal transplantation. Furthermore we want to evaluate the effect of mannitol on perioperative redox status in patients receiving renal transplantation using the oxidation-reduction potentials assessed with the RedoxSYS®system. We are planning to perform a double-blind randomized controlled trial. In the study, mannitol 20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9% in the dose of 5 ml / kg / BW. Patients will be randomized to receive either the mannitol or NaCl. The follow-up of the study is 24 hours. The following biomarkers will be determined befor induction of anesthesia and 24 hours after administration of study medication: CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and IL 18. Furthermore we want to perform sORP and cORP before induction of anesthesia, just before bolus of mannitol, 5 min after bolus of mannitol and after operation in anesthetic recovery room. Data will be collected, compared and published at the end of the study. It is planned to include a total of 34 patients in the study.

NCT ID: NCT02690272 Completed - Kidney Tranplant Clinical Trials

"Lived Experience, Representations and Psychic Processes in Patients Awaiting Kidney Transplantation"

LER-Psy-PAKT
Start date: February 29, 2016
Phase: N/A
Study type: Interventional

The kidney transplant remains the privileged treatment of the terminal renal insufficiency. This care is complex for the patient both on a medical surgical plan and by the psychic reorganizations. Among the temporary contraindications of transplantation, us retrouvonsdes psychological reasons. The research work consists in highlighting the psychic mechanisms of the subjects awaiting kidney transplant.

NCT ID: NCT02659891 Completed - Clinical trials for Kidney Transplantation

IVIg to Treat BK Viremia in Kidney Transplant Recipients

Start date: May 2016
Phase: Phase 1
Study type: Interventional

The overall goal of this study is to rapidly improve clearance of BK viremia with Immunoglobulin (Privigen®) thereby decreasing the potential for formation of alloantibodies in renal transplant recipients that have had immunosuppression reduction due to BK viremia. Our approach is to perform a prospective, randomized, placebo controlled trial intravenous immune globulin (IVIg; Privigen®) plus protocolized immunosuppression reduction versus placebo and protocolized immunosuppression reduction in patients with BK viremia post-kidney transplantation.

NCT ID: NCT02644395 Completed - Hypertension Clinical Trials

Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus

TT
Start date: January 18, 2013
Phase: Phase 3
Study type: Interventional

Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs to prevent rejection after kidney transplantation. However, the efficacy of preventing rejection comes at the cost of important side-effects. Among the most common side-effects is hypertension. Hypertension after kidney transplantation is clinically relevant, because it increases the risk of cardiovascular disease and is associated with increased graft loss and recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood and, therefore, the treatment is currently empiric. These and other investigators recently showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the kidney, namely the thiazide-sensitive sodium chloride cotransporter. Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to calcium channel blockers (CCBs) (currently usually the treatment of choice) for the treatment of CNI-induced hypertension. Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients with CNI-induced hypertension. Study design: Single-center, randomized cross-over trial. Study population: Kidney transplant recipients with a good functioning allograft (eGFR > 30 ml/min) who are hypertensive (daytime systolic blood pressure > 140 mm Hg) and who do not have proteinuria (< 1 g/day). Intervention: Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to 10 mg once daily). Main study parameters/endpoints: 24-hour blood pressure recording. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both drugs have long been registered for the treatment of hypertension. The side-effect profile of both drugs is considered to be equal. The burden of the study for the patients are blood pressure measurements using 30-minute automated blood pressure measurement and 24-hour ambulatory blood pressure measurement.

NCT ID: NCT02639949 Completed - Clinical trials for Kidney Transplant Recipients

Measuring and Improving Medication Adherence in Kidney Transplant Patients

Start date: January 2010
Phase: N/A
Study type: Interventional

Nonadherence to medication is a major obstacle to successful treatment of renal transplant patients. This study has two primary aims. The first is to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription. Participants will be randomly assigned to either group CBT or to standard care. The second aim is to pilot a novel strategy of adherence measurement - unannounced telephone pill counts, which has been shown to be a valid and reliable means to measure medication adherence in other patient populations. Participants will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to start of the intervention in order to establish baseline adherence and three pill counts will be conducted post-intervention. Tacrolimus trough concentration levels will also be collected as an additional biological measure of adherence.

NCT ID: NCT02633826 Completed - Clinical trials for Kidney Transplantation

Pre-formed Alloreactivity in Renal Transplant Recipients

Start date: November 2015
Phase:
Study type: Observational

This investigator-initiated study will analyse the role of pre-formed alloreactive T cells on acute rejection episodes and graft outcome in kidney transplant recipients after living donation.

NCT ID: NCT02576366 Completed - Clinical trials for Kidney Transplantation

Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus

Start date: June 2016
Phase: Phase 4
Study type: Interventional

Single center, open label crossover study with 2 treatment phases in healthy volunteers. The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed.

NCT ID: NCT02576145 Completed - Clinical trials for Kidney Transplantation

A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)

Start date: April 2003
Phase: Phase 4
Study type: Interventional

This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.