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Kidney Replacement clinical trials

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NCT ID: NCT06445205 Recruiting - Clinical trials for Kidney Transplant Rejection

Utilising Volumetric Absorptive Microsampling (VAMS) Technology to Monitor Tacrolimus and Creatinine

Start date: February 13, 2024
Phase:
Study type: Observational

Tacrolimus is a medicine given to try and stop rejection of a new kidney after transplant surgery. If too much taken the kidney may be damaged. If not enough taken, the risk of rejection is increased. Creatinine is a waste product made by the muscles and is normally removed from the body by the kidneys. If kidney function gets worse, the creatinine level in the blood goes up and means the new new kidney is not working properly. It is important to monitor levels of tacrolimus and creatinine regularly, to keep the kidney as healthy as possible. Regular monitoring also aids with balancing the amount of tacrolimus that patients need to take. The COVID-19 pandemic led to changes in the delivery of transplant services. One such changes was a move to the use of point-of-care, and at home devices. The study involves the set-up a new method in an NHS laboratory to test tacrolimus and creatinine levels in blood collected in the normal blood tubes and to compare the results with this new collection device, to see if the results are the same. If the results match, patients will continue to collect a blood sample using the new devices and send it to the laboratory. This will save both patients and the NHS time and money as they will not have to travel to a hospital to have their bloods taken.

NCT ID: NCT06374121 Not yet recruiting - Kidney Replacement Clinical Trials

Kidney Perfusion With or Without Absorption

POWER
Start date: June 2024
Phase: N/A
Study type: Interventional

In this single-center, pilot, prospective, randomized study, the investigators will compare the biochemical profiles of the perfusate and the functional parameters of five kidneys perfused with Integrated PerLife® system and "PerSorb ECOS-300CY ™" sorbent (adsorption groups) with the profiles of the perfusate and functional parameters of five matched kidneys perfused with Integrated PerLife® system only (non-adsorption group). Kidneys from marginal donors with a clinical indication to pre-transplant histological evaluation (donor >70-years-old or aged 60 to 69 years but with hypertension, diabetes and/or clinical proteinuria) will be allocated to perfusion with or without adsorption using a 1:1 randomization ratio. When both donor kidneys will have a score from 0 to 4, the two kidneys will be used for two single transplants. When one kidney will have a score from 0 to 4 and the other kidney will have a score of 5 or more, and when both kidneys will have a score from 5 to 7, the two kidneys will be transplanted together into the same recipient. If one kidney will have a score from 5 to 7 and the other kidney will have a score of 8 or greater, the two kidneys will be discarded. With the use of the minimization method, the randomization will be planned in order to have the same number of single or dual transplants in the perfusion kidney groups with or without adsorption. Donor selection, kidney evaluation and allocation and recipient management will be based on per center practice.

NCT ID: NCT06374095 Not yet recruiting - Kidney Replacement Clinical Trials

1 vs 7 RATG Infusions in Renal Transplantation

ONSET
Start date: June 2024
Phase:
Study type: Observational

This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid (progressively tapered post-transplant) and maintenance therapy with calcineurin inhibitors and mycophenolate mofetil/mycophenolic acid in 75 recipients (25 Patients and 50 Reference-Patients) of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center.

NCT ID: NCT06182475 Not yet recruiting - Clinical trials for End Stage Renal Disease

Development and Test of a Communication Skills Training for Transplant Providers - Aims 2 & 3

EPPComm
Start date: January 2026
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to understand the communication occurring between Black and Caucasian patients and their transplant providers during transplant evaluation consultations and assess relationships between these communicative elements and patient and provider factors, patient-reported outcomes and living donor transplant outcomes - living donor referrals, evaluations, and transplants. We will use these findings to inform the development of a communication skills training for transplant providers and test the impact of the training on providers' communication about live donor kidney transplants with Black and Caucasian patients and living donor transplant outcomes. The main questions it aims to answer are: - How does the use of the use of instrumental, relational and affective communication by patients and providers during the transplant consultation differ by patient and provider factors, patient-reported outcomes and patient ethnicity? - What elements of instrumental, relational and affective communication will be predictive of live donor kidney transplant (LDKT) process outcomes (LD inquiries and evaluations, and actual LDKTs)? Participants will be asked to complete brief surveys before and after the transplant consultation and to give permission for the consultation to be audiorecorded. This data will be used to develop a training to educate providers on the key communication factors predictive of LDKT process outcomes specific to Black and Caucasian patients, and provide guidance on their application during patient consultations. Researchers will then compare communication and patient-reported and LDKT process outcomes between trained and untrained providers to see whether the training has any effect on living donor inquiries and evaluations, and actual LDKTs.

NCT ID: NCT06129617 Recruiting - Liver Cirrhosis Clinical Trials

Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction

ADVOMITTENT
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

In the planned randomized controlled prospective pilot study, we aim to evaluate ADVOS compared with conventional hemodialysis regarding the elimination of protein-bound toxins in patients with therapy-refractory hepatorenal syndrome. The study will be performed in a regular non-ICU ward with a large experience in the use of the ADVOS therapy.

NCT ID: NCT05473143 Recruiting - Critical Illness Clinical Trials

Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy

Probe-Fluid
Start date: April 3, 2023
Phase: N/A
Study type: Interventional

A pilot randomized clinical trial comparing a protocol-based fluid management strategy to usual care in critically ill patients receiving kidney replacement therapy. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.

NCT ID: NCT04166994 Completed - Kidney Replacement Clinical Trials

Pilot of IMPACT Intervention at the University of New Mexico

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

Kidney transplant recipients (KTR) are at greater risk of weight gain, diabetes and cardiovascular events post-transplant; but medications are limited in their effectiveness, and patients may face contraindications and unwanted side effects, given their complex post-transplant immunosuppression regimen. The investigators will pilot a randomized-controlled trial to test the feasibility and acceptability of a culturally-appropriate, multi-behavior (diet and exercise) lifestyle intervention for 20 American Indian, Hispanic/Latino(a), and White KTRs. Critical components of the pilot trial include: (a) an individually tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability; and, (b) the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments and to collect all questionnaire data.

NCT ID: NCT03965559 Completed - Clinical trials for Kidney Transplant Rejection

The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant

Start date: November 1, 2015
Phase:
Study type: Observational

At present, the number of end-stage kidney disease patients is increasing. Kidney transplant surgery is one of the treatments that give patients a better survival rate than hemodialysis or abdominal dialysis. In Thailand, there were 5,729 kidney transplant patients or 88.9 cases per million population in 2012. Among this number, 465 were new surgical patients or 7.2 cases per million population. From the year 2007-2012, the survival rate of the kidney donor from living donor kidney transplant (LDKT) was 98.5 percent and 93.3 percent at 1 and 5 years, respectively. The most common cause of graft loss was chronic rejection by 33% of all graft loss. However, 16.1 percent were unknown reasons for graft loss. The research question is "In patients with kidney transplantation who suspected graft rejection" Is it true that doing plasmapheresis or DFPP is no different. The researcher therefore conducted a comparative study. Is plasmapheresis or DFPP effective or different side effects?

NCT ID: NCT03464149 Completed - Clinical trials for Secondary Hyperparathyroidism

The Longitudinal PTH-Study

Start date: March 20, 2018
Phase:
Study type: Observational

The main study aim is to quantify the agreement between the analytical results provided by two third generation and two second generation Parathyroid hormone (PTH) assays. The primary comparison will be performed between the second-generation PTH assay"Intact PTH assay" from Siemens Healthcare Diagnostics Inc. and the third-generation PTH assay "biointact (1-84)" from Roche Diagnostics in terms of a Bland-Altman analysis. Several studies have evaluated the correlation between various PTH assays at a single time-point, but no previous study has tested the hypothesis that longitudinal changes in PTH levels, which are important for making treatment decisions, can be monitored by several PTH assays alike. To this aim, the key secondary objective is to analyze the longitudinal variance in PTH over the course of 1 year, using each of two assays of the second and third generations, respectively. Other secondary objectives include determining changes in serum phosphate, serum calcium, fibroblast growth factor 23 (FGF23), with respect to treatment decisions. For clinical applicability of the results to be obtained here, an important goal of the present study will be not to influence treatment decisions, which will remain independent of the study investigators, at the full responsibility of the hemodialysis physicians. At every quarterly blood draw over the course of one year, the investigators will freeze the serum from 100 patients, and at the end of 4 quarters the investigators will analyze PTH-levels using the following assays: Intact Parathyroid Hormone (Advia Centaur, Siemens Healthcare), PTH-Intact (Cobas, Roche), PTH (1-84) - The agreement between the PTH assays will be analyzed at baseline, as well as at the subsequent quarterly evaluation time-points by Bland-Altman analysis and complemented by Passing-Bablok regression. The longitudinal changes in PTH will be displayed graphically and analyzed by estimating the within-patient variance across time, the between patient variance at each time-point as well as effects on the mean log-PTH level due to course of disease and therapeutic interventions from a linear mixed model.