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Renal Anemia clinical trials

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NCT ID: NCT05970172 Recruiting - Clinical trials for Chronic Kidney Disease

A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help the bone marrow make more red blood cells. These are often given together with iron. This treatment is also available to children and teenagers with CKD. However, there are some safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option for treating anemia in children and teenagers with CKD. In this study, children and teenagers with CKD and anemia will take roxadustat for up to 52 weeks to treat their anemia. The main aim of the study is to learn how roxadustat affects anemia in children and teenagers with CKD. This is an open-label study which means the children and teenagers in the study and the clinic staff know they will be taking roxadustat. In this study, the children and teenagers with CKD who need treatment for anemia can take part. Those currently being treated with an ESA will be switched to roxadustat. Those who have not been treated with an ESA can start on roxadustat straight away. All children and teenagers in the study will take roxadustat 3 times a week for up to 52 weeks (1 year). They will start on a fixed dose of roxadustat for 4 weeks. Blood samples will be taken regularly to check hemoglobin levels. The roxadustat dose may be changed if the blood levels of hemoglobin are too high, too low, or change too quickly. After 4 weeks the dose may be changed, if needed, to keep blood levels of hemoglobin in the blood to just below the normal range. Firstly, teenagers will take roxadustat. 10 teenagers will take their fixed dose of roxadustat for 4 weeks. They will give blood samples to help the researchers work out the most suitable dose for the rest of the teenagers in the study. When the rest of the teenagers start taking roxadustat at the most suitable dose for teenagers, 10 children will take roxadustat for 4 weeks. These 10 children will give blood samples to help the researchers work out the most suitable dose for the rest of the children in the study. Then, the rest of the children will take roxadustat at the most suitable dose for children. There will be many clinic visits during the study. Overnight hospital stays are not expected. There will be 1 visit every 2 weeks for the first 4 weeks of taking roxadustat, then every 4 weeks until the end of treatment. Finally there is 1 visit 4 weeks after treatment has finished. During most visits, the children and teenagers will have their vital signs checked (blood pressure, body temperature and heart rate). Fluid status (how much water is in the body) will also be checked for those who need dialysis. The children and teenagers will also have blood tests and the study doctors will check for any medical problems. The children and teenagers will have a medical examination before their first dose of roxadustat and again at about 24-week (6-month) and 52-week (13-month) visits. They will have an electrocardiogram (ECG) before their first dose of roxadustat and again at the 12-week, 24-week, 36-week, and 52-week visit. They will also have urine tests at the 4-week, 24-week and 52-week visits. At the 52-week visit, the children and teenagers will also have blood tests for hemoglobin and iron levels. The study doctors will also check for any medical problems.

NCT ID: NCT05951192 Completed - Anemia Clinical Trials

A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease

ROQ-IT
Start date: July 1, 2023
Phase: Phase 4
Study type: Interventional

Investigator-initiated, interventional, prospective study to assess the clinical and operational effectiveness of daprodustat in adult patients receiving in center hemodialysis or peritoneal home dialysis who are transitioning from Mircera to daprodustat.

NCT ID: NCT05864261 Completed - Renal Anemia Clinical Trials

Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers

Start date: May 15, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers

NCT ID: NCT05629598 Recruiting - Renal Anemia Clinical Trials

A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .

Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.

NCT ID: NCT05265325 Active, not recruiting - Renal Anemia Clinical Trials

A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis

Start date: May 3, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II study to evaluate the safety and efficacy of AND017 in renal anemia patients on dialysis

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: NCT05035641 Completed - Renal Anemia Clinical Trials

A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

Start date: October 18, 2021
Phase: Phase 2
Study type: Interventional

This is a pilot phase II study to evaluate the safety and efficacy of AND017 in NDD-CKD patients

NCT ID: NCT04925661 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia

Start date: September 29, 2021
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability , pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia.

NCT ID: NCT04899661 Recruiting - Renal Anemia Clinical Trials

A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia

Start date: August 6, 2021
Phase:
Study type: Observational

In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells. In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat. The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.

NCT ID: NCT04775615 Not yet recruiting - Renal Anemia Clinical Trials

Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Healthy Subjects.

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days.