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Kidney Failure, Chronic clinical trials

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NCT ID: NCT05340426 Withdrawn - Clinical trials for Kidney Failure, Chronic

Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease

Start date: January 31, 2024
Phase: Phase 1
Study type: Interventional

The mismatch between organ supply and demand results in the deaths of thousands of Americans each year. Our research group aims to solve this unmitigated health care crisis by translating advances in xenotransplantation to humans and expanding organ supply in a sustainable fashion using genetically modified pigs as a source of organs. We propose here a phase I clinical trial of porcine kidney xenotransplantation into 20 people with end-stage kidney disease. Source donor animals are pigs with 10 gene edits (10-GE) which attenuate immunologic harm to the kidney xenograft. 10-GE pigs are housed in a designated pathogen-free facility within 30 minutes of the transplantation center. Xenotransplantation procedures follow conventional practices currently employed in allotransplantation and comply with multiple regulatory standards to ensure ethical treatment of research subjects and source animals. Recruitment and xenotransplantation will occur over 5 years with study follow-up extending 1 year after xenotransplantation. Primary outcome variables surround patient safety, such as patient survival and the rate of zoonotic disease transmission. Secondary outcome variables include commonly used metrics of graft survival and function.

NCT ID: NCT04320290 Withdrawn - Hepatitis C Clinical Trials

HCV + to HCV - Kidney Transplant

Start date: May 21, 2020
Phase: Phase 4
Study type: Interventional

This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

NCT ID: NCT04048707 Withdrawn - Cirrhosis Clinical Trials

Angiotensin 2 for Hepatorenal Syndrome

ANTHEM
Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure. The current treatment available in the United States is a combination of octreotide and midodrine, which are meant to decrease the release of those hormones and raise the blood pressure, respectively, which would increase blood flow to the kidneys. Angiotensin 2 (Ang2) is a new vasopressor drug that was approved by the FDA in December 2017 for patients with low blood pressure and has been shown to have similar effects to octreotide and midodrine. This study will investigate whether Ang2 reverses HRS among patients admitted to the intensive care unit (ICU) at Ronald Reagan Medical Center. Our study population will be patients with HRS who are already or will be admitted to the ICU. HRS will be defined by new internationally accepted guidelines published by the International Club of Ascites. All patients who are consented will undergo an Ang2 response trial, where low-dose Ang2 will be administered for 4 hours to see how the patients respond. This will help us characterize the nature of the patients' kidney failure for later analysis. Patients will then be randomized into the control group or the study group. Patients in the control group will receive octreotide (a subcutaneous injection) and midodrine (an oral drug). Patients in the study group will continue receiving intravenous infusion of Ang2. Patients in both groups will also receive albumin, a protein found commonly in human blood. Treatment will continue in both groups for four days, until complete reversal of HRS, dialysis, or death. Our primary outcome will be rate of reversal of HRS, defined as improvement in kidney function.

NCT ID: NCT03623568 Withdrawn - Hepatitis C Clinical Trials

Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

Start date: February 15, 2019
Phase: Phase 4
Study type: Interventional

This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

NCT ID: NCT03043144 Withdrawn - Malnutrition Clinical Trials

Taste And Smell TEsting in End Stage Renal Disease

TASTE ESRD
Start date: February 15, 2017
Phase: N/A
Study type: Observational

Malnutrition is an important complication of advanced kidney disease and impairment in smell and taste may affect nutritional status. This study will examine the association between impairment in smell and taste and nutritional and functional markers among patients with end stage renal disease, as well as risk factors for smell and taste impairment.

NCT ID: NCT02368249 Withdrawn - Kidney Failure Clinical Trials

Does Terlipressin Improve Renal Outcome After Liver Surgery

TIROL
Start date: January 2020
Phase: Phase 2
Study type: Interventional

The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.

NCT ID: NCT02284230 Withdrawn - Clinical trials for Kidney Failure, Chronic

The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure

LiRA2
Start date: December 2014
Phase: Phase 2
Study type: Interventional

The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives include various clinical and biochemical cardiovascular and safety parameters. We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate other cardiovascular risk factors.

NCT ID: NCT01073189 Withdrawn - Clinical trials for Kidney Failures, Acute

Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury

IR-FTA
Start date: April 2010
Phase: Phase 4
Study type: Interventional

Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where patients will receive standard supportive therapy with diuretics versus intra-renal delivery of the vasodilator fenoldopam mesylate. Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a prolonged course of diuretics or undergo placement of a catheter within the renal arteries that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a high dose vasodilator may reverse the decline of renal function in patients with severe acute kidney injury.

NCT ID: NCT00837655 Withdrawn - Insulin Resistance Clinical Trials

Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)

SIR
Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receiving maintenance hemodialysis.

NCT ID: NCT00807274 Withdrawn - Kidney Failure Clinical Trials

Renal Function in Adults With Congenital Heart Disease.

Start date: September 2008
Phase: N/A
Study type: Observational

Impaired kidney function is associated with a poor outcome in patients with heart failure but it is not known of this is the case for patients who have been born with their heart condition (congenital heart disease). This study aims to investigate how frequently patients with congenital heart disease have kidney disease and whither this does have an impact on their outcome. The hypothesis is that kidney dysfunction will be common in these patients and may have an impact on long-term health and life-expectancy.