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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT05094934 Terminated - Clinical trials for Chronic Kidney Disease

A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function

Start date: November 9, 2021
Phase: Phase 1
Study type: Interventional

Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level. The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function. All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day. The study will last for about 9-14 weeks. Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits. Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded. Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements. Women can only take part in the study if they cannot get pregnant.

NCT ID: NCT05092347 Recruiting - Clinical trials for Chronic Kidney Disease (CKD)

Study for Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen

Start date: August 2, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA). The secondary objectives of the study are to determine/assess the following for REGN5459 (Part A) or REGN5458 (Part B): - Dose regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels - Effect on calculated panel-reactive antibody (cPRA) levels - Time to maximal and clinically meaningful reduction in anti-HLA alloantibody levels - Duration of the effect of study drug on the reduction of anti-HLA alloantibodies - Effect on circulating immunoglobulin (Ig) classes (isotypes) - Pharmacokinetics (PK) properties - Immunogenicity

NCT ID: NCT05090865 Recruiting - Clinical trials for Chronic Kidney Disease

Dietary Potassium Liberalization in Pre-Dialysis Patients

DK-LIB
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design. Participants will receive home delivery of fruit and vegetables with either higher or lower potassium content in a random order. Clinical chemistry markers from blood and urine samples, blood pressure, physical functioning and health related quality of life will be assessed throughout the duration of the trial. This study will also measure their physical functioning, using a chair stand test. The results of this study could change the dietary recommendations for people with CKD related to potassium.

NCT ID: NCT05086185 Enrolling by invitation - Hyperkalemia Clinical Trials

Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients

Start date: June 29, 2021
Phase:
Study type: Observational

High blood potassium levels (hyperkalemia) is a major problem for people with kidney failure undergoing hemodialysis treatment. In order to reduce the risk of hyperkalemia, people with kidney failure are advised to limit or avoid high-potassium foods. However, high-potassium foods comprise many healthy food choices, including commonly consumed fruits and vegetables that are key sources of dietary fiber, and other important nutrients. Risk of hyperkalemia from dietary potassium intake is most notable in the first few hours after a meal when ingested potassium enters the bloodstream. In general, dietary potassium is very well absorbed. However, dietary fiber has been shown to increase the proportion of dietary potassium that is excreted in stool. Based on these findings, it has been proposed that fiber may help to lower the risk of hyperkalemia in people with kidney disease. It remains unclear whether dietary fiber increases potassium excretion in stool by reducing the absorption of dietary potassium, or by drawing body potassium into the bowels by increasing stool bulk. The distinction may be important, as reducing potassium absorption would be expected to be of greater benefit in preventing hyperkalemia caused by eating high-potassium foods. In this study, the investigators will assess whether a fiber supplement can reduce the effect of dietary potassium from orange juice on blood potassium levels in people with kidney disease undergoing maintenance hemodialysis treatment.

NCT ID: NCT05085275 Active, not recruiting - Clinical trials for Renal Insufficiency, Chronic

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

FRONTIER
Start date: March 30, 2022
Phase: Phase 3
Study type: Interventional

A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.

NCT ID: NCT05082584 Suspended - Clinical trials for Anemia of Chronic Kidney Disease

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents

CORRECTION
Start date: January 2025
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of chronic kidney disease (CKD) naive to erythropoiesis-stimulating agent (ESA) treatment.

NCT ID: NCT05082571 Suspended - Clinical trials for Anemia of Chronic Kidney Disease

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease

CONVERSION
Start date: January 2025
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA).

NCT ID: NCT05081648 Completed - Clinical trials for Chronic Kidney Diseases

Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention

MuST
Start date: January 3, 2022
Phase: N/A
Study type: Interventional

The aims of this study are to: - Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder). - Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder). - Analyze the intensity of pain perceived by the patient with each cannulation technique under study.

NCT ID: NCT05075408 Completed - Clinical trials for Chronic Kidney Disease Associated Moderate to Severe Pruritus

To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

NemoCKDaP
Start date: December 29, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of nemolizumab compared to placebo at reducing the intensity of pruritus after a 12-week treatment period in adult hemodialysis participants with moderate to severe pruritus.

NCT ID: NCT05072574 Completed - Clinical trials for Chronic Kidney Diseases

Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease

ERCANUT
Start date: April 23, 2021
Phase: N/A
Study type: Interventional

This study evaluates the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.