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Kidney Transplantation clinical trials

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NCT ID: NCT04828460 Recruiting - Covid19 Clinical Trials

Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

COVATRANS
Start date: February 9, 2021
Phase:
Study type: Observational

Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients. It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression. Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.

NCT ID: NCT04815954 Recruiting - Clinical trials for Urinary Tract Infections

Early vs Late Urinary Catheter Removal After Renal Transplantation

ELUCATR
Start date: March 26, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to compare frequency of UTI, urine leak and need for reoperation in patients after renal transplant with early or delayed Foley catheter removal. The hypothesis of the ELUCATR trial is that there is no need to keep Foley catheter longer than 24 hours after kidney transplant due to lack of significant effect on urological complications (urine leak, ureter strictures). Early removal can also reduce urinary tract infections. Main advantage of urinary catheter placement is continual diuresis monitoring and lower bladder pressure. Some hypothesize that increased pressure can disrupt ureteroneocystostomy with resultant urinary fistula. Clinical practice is to remove the catheter between 1-10 post-transplant day. Only few studies described removal of Foley catheter in the first 48 hours. There is no level 1 evidence for timing of urinary catheter removal after kidney transplantation. Urinary tract infection is a common complication after KTx occurring in about 7-80% patients. Studies suggest direct negative effect of UTI on long-term renal allograft function. There are several independent risk factors for developing UTI: female sex, diabetes and obesity. Duration of catheterization is a modifiable risk factor. Urine leak and ureter stenosis are relatively frequent surgical complications of kidney transplantation. Urine leaks occur in 2-9% of all kidney transplants. Most of them happen within 3 months after surgery. Urinary fistula contributes to mortality and graft loss. Majority of them need intervention with nephrostomy, pigtail ureteral stent or surgery. Anastomotic or ureter stenosis occurs in 3.1% of all kidney transplants and is usually resolved with open ureteroneocystostomy. Diagnosed and treated early, it does not affect patient and graft survival. There are no solid data documenting influence of the urinary bladder catheterization on fistulas, urinomas, ureter strictures and need for reoperation in this set of patients. European Best Renal Practice Guidelines recommend removal of the catheter as early as possible, however a randomized trial on timing and adverse event rates (urinary tract infection, urinary leakage) is needed.

NCT ID: NCT04803058 Recruiting - Clinical trials for Kidney Transplantation

A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PERSPECTIVE)

Start date: December 14, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in de novo living donor renal transplant recipients

NCT ID: NCT04803006 Recruiting - Clinical trials for Kidney Transplantation

A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PANORAMA)

Start date: January 17, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in de novo living donor renal transplantation.

NCT ID: NCT04794582 Recruiting - Clinical trials for Postoperative Complications

Prevention of Incisional Hernia After Renal Transplantation

Start date: August 31, 2022
Phase: N/A
Study type: Interventional

Randomized clinical trial to determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by reduction in the incidence of incisional hernia at 2 years post-transplantation.

NCT ID: NCT04791098 Recruiting - Clinical trials for Kidney Transplantation

Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital

PREVAGREF
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.

NCT ID: NCT04783441 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Use of CGM in Kidney Transplant Recipients

Start date: June 29, 2021
Phase: N/A
Study type: Interventional

The investigators want to study the impact CGM (continuous glucose monitoring) has on patients glycemic control as determined by time in range (TIR 70-180 mg/dL) in the Diabetic Kidney Transplant population.

NCT ID: NCT04779957 Recruiting - Clinical trials for Kidney Transplantation

Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy

RAIPONS
Start date: October 1, 2021
Phase: Phase 2
Study type: Interventional

Graft nephrectomy is associated with massive allo-sensitization following this event. The occurrence of anti-HLA antibodies is a major barrier to perform a second kidney transplantation. Investigators propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy. The primary endpoint evaluated here is the occurrence of serious infectious complications following graft nephrectomy, with a treatment by Tocilizumab. Secondary endpoints evaluated here are - to evaluate all complications after graft nephrectomy, - and the Tocilizumab effectiveness to reduce anti-HLA antibodies at one year post nephrectomy.

NCT ID: NCT04773392 Recruiting - Clinical trials for Kidney Transplantation

Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

SIMPLE
Start date: November 23, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid.

NCT ID: NCT04757883 Recruiting - Clinical trials for Kidney Transplant Recipients

Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients

COVATRHUS
Start date: February 2, 2021
Phase:
Study type: Observational

The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2. The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. These patients will be vaccinated as part of routine care with a CoV-2 SARS vaccine licensed in France. In this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against SARS CoV-2 and the specific cellular response of SARS Cov-2 by quantiferon and in vitro lymphocyte stimulation assays.