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Kidney Failure, Chronic clinical trials

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NCT ID: NCT05021731 Not yet recruiting - Kidney Failure Clinical Trials

Short-course Rifamycin-based Regimens for Latent Tuberculosis in Patients With End-stage Kidney Disease

Start date: April 20, 2024
Phase: Phase 4
Study type: Interventional

Objective To determine if treatment completion with a 4-month rifampin (4R) or 3-month rifapentine (P) + isoniazid (H) weekly for 12 weeks (3HP) regimens is better than with a 3-month (3HR) regimen for treatment of latent tuberculosis (TB) infection (LTBI) in patients with end stage kidney disease. Methods Design: Multicenter, prospective, parallel-group, open-label, controlled clinical trial. Study population: All adult patients with ESKD in who treatment for LTBI is prescribed at 7 hospitals. Interventions: Patients who accept participation, will be randomly assigned to one of the 3 arms: 3HR (control) (90 doses), 4R (120 doses) or 3HP (12 doses). Outcome: Proportion of participants who discontinue permanently the assigned treatment. Follow-up: Periodic assessment for permanent or temporary discontinuation, and adverse events of the assigned treatment. Sample size: 225 subjects (75 per arm) will be needed to demonstrate, if exists, a 0.16 decrease in permanent discontinuation rates in the experimental arms (4R and 3HP) with respect to the control arm (3HR), with α= 0.025, β= 0.20, and 5% expected losses, and assuming a 0.25 proportion of permanent discontinuation in the control.

NCT ID: NCT04827290 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

Assessment of the Effect of Restriction on Alimentary AGE in Progression of Chronic Kidney Disease

CKD AGE
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients

NCT ID: NCT04660383 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Start date: December 2022
Phase: N/A
Study type: Interventional

Investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with end stage kidney disease (ESKD). With intervention of thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (MIP).

NCT ID: NCT03845530 Not yet recruiting - Inflammation Clinical Trials

The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin

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

The aim of this study is to determine the levels of alpha-defensin throughout the hemodialysis course compared to the levels at the end of a course of peritoneal dialysis, as a reflection of the inflammatory burden.

NCT ID: NCT03160430 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis

Start date: November 22, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive hemodialysis as standard of care. Part B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with SoC. The primary objective of the study is to evaluate if treatment with RVX000222 in combination with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo and SoC.

NCT ID: NCT02573675 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

An Assessment on Current Outcomes of Peritoneal Dialysis in Korea

PDKOREA
Start date: November 2015
Phase: N/A
Study type: Observational

In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will be investigated retrospectively using the Korean Health Insurance Review and Assessment Service (HIRA) database.

NCT ID: NCT02447822 Not yet recruiting - Kidney Failure Clinical Trials

Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)

Start date: June 2015
Phase: Phase 4
Study type: Interventional

This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.

NCT ID: NCT02435732 Not yet recruiting - Kidney Failure Clinical Trials

CINRYZE as a Donor Pre-treatment Strategy in Kidney Recipients of KDPI>60%

Start date: December 2020
Phase: Phase 1
Study type: Interventional

Limiting brain death-induced organ injury through a systemic anti- inflammatory medical management should allow for improvement in the quality of transplanted organs, and as a result, clinical improvement in post-transplant outcomes represented by a decrease in the incidence of delayed graft function (DGF) after transplantation. The specific aim is to evaluate the effect of C1INH (CINRYZE) as a donor pre-treatment strategy to decrease systemic inflammation and decrease the incidence of DGF in Expanded Criteria Donors (ECD), currently identified as donors with Kidney Donor Profile Index (KDPI) greater than or equal to 60%.

NCT ID: NCT01981083 Not yet recruiting - Hemodialysis Clinical Trials

Egg Albumin-Based Protein Supplement Versus Renal-specific Supplement in Hemodialysis Patients

Start date: November 2013
Phase: Phase 4
Study type: Interventional

Malnutrition is seen frequently in hemodialysis units in most developing countries. Malnutrition increases morbidity and mortality in this population and its treatment improves patient survival and health status The purpose of this study is to compare two strategies to improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml) versus egg albumin-based protein supplement (30 g) on a daily basis. This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment (SGA) in addition to most used biochemical markers to determine nutritional status.

NCT ID: NCT01828372 Not yet recruiting - Obesity Clinical Trials

Quantification of Drugs and Their Degradation Products

Start date: May 2013
Phase: N/A
Study type: Interventional

The study includes two study parts in which blood is collected from the patients. Study part A (observational study, already received positive ethics committee vote; Our sign: 12-330): Use of blood samples gathered during routine blood withdrawal Study part B (interventional study in the sense of additional blood samples but without an investigational product): Optional, for further pharmacokinetic questions: blood withdrawal with a maximum of 20 ml ( ten tubes of 2 ml each) within a maximal study length of four weeks. The primary objective of this study is to gain an overview about drug concentrations in plasma and/or cerebrospinal fluid (CSF), in order to determine pharmacokinetics of drugs in patients. Any drug may be tested, however the initial focus is on antiinfective, antineoplastic, and antipsychotic drugs. Many published studies show that there is a profound lack of information on pharmacokinetics and interactions of many commonly used drugs in clinical routine, and that drug concentrations, if controlled by therapeutic drug monitoring, are not in the therapeutic range (provided that such ranges are known at all).