Study on Roxadustat for Treating Anemia in Children with Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the treatment of anemia in children and adolescents who have Chronic Kidney Disease (CKD). Anemia is a condition where the body does not have enough healthy red blood cells to carry oxygen, which can make a person feel tired and weak. CKD is a long-term condition where the kidneys do not work as well as they should. The study will use a medication called roxadustat, which is taken as a tablet. Roxadustat is being tested to see how well it works and how safe it is for treating anemia in young patients with CKD.

In this study, participants will take roxadustat tablets for a period of time, and their health will be monitored to see how the medication affects their anemia. The study will also compare roxadustat to other treatments that are commonly used for anemia, such as methoxy polyethylene glycol-epoetin beta, epoetin alfa, and darbepoetin alfa. These are medications that help the body produce more red blood cells. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to evaluate the effectiveness and safety of roxadustat in treating anemia in children and adolescents with CKD. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather information on how the medication affects their condition. The study aims to provide valuable information that could help improve the treatment of anemia in young patients with CKD in the future.

1 joining the study

Upon joining the study, the participant will begin the treatment phase. This involves taking the medication roxadustat, which is used to treat anemia associated with chronic kidney disease.

The participant will receive roxadustat in the form of film-coated tablets. The available dosages are 5 mg, 20 mg, and 50 mg. The medication is taken orally.

2 treatment period

The treatment period lasts for 24 weeks. It begins with 4 weeks of a fixed dose of roxadustat, followed by 20 weeks where the dose may be adjusted based on the participant’s response.

During this time, the participant’s hemoglobin (Hb) levels will be monitored to assess the effectiveness of the treatment.

3 monitoring and assessments

Throughout the study, various assessments will be conducted. These include monitoring Hb levels, evaluating the participant’s response to the medication, and adjusting the dosage as needed.

Additional assessments include checking for any side effects, such as cardiovascular or thrombotic events, and conducting safety evaluations through laboratory tests and physical examinations.

4 end of treatment evaluation

At the end of the 24-week treatment period, the participant’s Hb levels will be compared to baseline levels to determine the change and effectiveness of the treatment.

The study will also evaluate the participant’s quality of life and any changes in fatigue levels using specific questionnaires designed for pediatric participants.

5 extended observation

After the initial 24-week treatment period, the study may continue to observe the participant for up to 52 weeks to gather additional data on the long-term effects and safety of roxadustat.

During this time, the participant may continue to receive the medication and undergo regular assessments as outlined in the study protocol.

Who Can Join the Study?

Written permission and privacy agreement must be obtained from the participant or their parent/legal guardian before any study-related activities. This includes stopping any medications that are not allowed in the study.
Female participants must agree not to breastfeed from the start of the study until 4 weeks after the last dose of the study medication, roxadustat.
Female participants must not donate eggs from the start of the study until 4 weeks after the last dose of roxadustat.
Male participants with female partners who can become pregnant must use birth control during the study and for 4 weeks after the last dose of roxadustat.
Male participants must not donate sperm during the study and for 4 weeks after the last dose of roxadustat.
Male participants with pregnant partners must agree to not have sexual intercourse or use a condom during the partner’s pregnancy and for 4 weeks after the last dose of roxadustat.
The participant and/or their parent or legal guardian must agree not to join another study while participating in this one.
The participant must be between 2 and 18 years old at the first study visit.
The participant must have been diagnosed with anemia (a condition where you don’t have enough healthy red blood cells) related to Chronic Kidney Disease (CKD), which is a long-term condition where the kidneys do not work as well as they should. This includes those not on dialysis or those on different types of dialysis.
Participants not on dialysis must have a kidney function test result of less than 60 mL/min per 1.73 m², which is a measure of how well the kidneys are working.
Participants who are already being treated with ESA (a medication that helps the body make more red blood cells) should have a hemoglobin level (a measure of red blood cells) between 10.0 and 12.0 g/dL. Those who have not been treated with ESA can have a hemoglobin level of 11 g/dL or less.
The participant must have a ferritin level (a measure of stored iron in the body) greater than 100 ng/mL or a TSAT (a measure of how much iron is available in the blood) value greater than 20%.
The participant must have ALT and AST (liver enzymes) levels that are no more than twice the normal limit and TBL (total bilirubin, a substance made by the liver) levels that are no more than 1.5 times the normal limit at the enrollment visit.
The participant must either be currently treated with ESA or have not been treated with ESA before. If treated, they must have been on a stable dose for at least 4 weeks before the study. If not treated, they must have had no ESA exposure or limited exposure in the 4 weeks before the study, or they must have stopped ESA treatment at least 8 weeks before the study.
Female participants must not be pregnant and must agree to use birth control if they can become pregnant, from the time they give consent to join the study until at least 4 weeks after the last dose of the study medication.

Who Cannot Join the Study?

Patients who have any other serious health condition that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent blood transfusion.
Patients who have a known allergy to the study medication or its ingredients.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that could affect their ability to participate in the study.
Patients who have a history of non-compliance with medical treatments.
Patients who have a condition that requires them to take medications that could interfere with the study medication.
Patients who have a history of certain types of cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Hospices Civils De Lyon	Lyon	France
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev	Sofia	Bulgaria
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Uniwersytecki Szpital Dzieciecy W Krakowie	Cracow	Poland
Children’s Hospital Zagreb	Zagreb	Croatia
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Azienda Ospedaliera di Padova	Padua	Italy
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou	Athens	Greece
Hippokration Hospital	Athens	Greece
KBC Zagreb	Zagreb	Croatia
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Fakultni Nemocnice Brno	Brno	Czechia
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara	Timisoara	Romania
Hospital Universitario 12 De Octubre	Madrid	Spain
Emergency Institute For Cardiovascular Diseases And Transplant	Targu Mures	Romania
Narodny Ustav Detskych Chorob	Bratislava	Slovakia
Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca	Cluj Napoca	Romania
Children’s Health Ireland	Dublin	Ireland
Hopital Jeanne De Flandre	Lille	France
University Hospital Consorziale Policlinico	Bari	Italy
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola	Brussels	Belgium
Clhqgvfyk Utcbqcoicaiymu Sktebcblb	Woluwe-Saint-Lambert	Belgium
Afjsthq Ofheovemtpp Ujvkonzcdjrti Cghfcwblixfu Daspt Sxvvvh E Djtgi Sgtxwnx Da Tgajzr	Turin	Italy
Ksuxoysvlpmmuhvfkvs Bxug	Bonn	Germany
Fritlgge nzhexjoed Mjetl a Hqwdgmj	Prague	Czechia
Ulhdjei Uemukcpruc Hdunwzrr	Uppsala	Sweden
Htusc Bwghky Hc	Bergen	Norway
Hufepnzs Uerdyktrst Clbqhod Hzaydaaz	Helsinki	Finland
Ezqpqdg Uatldgdcesqs Mmfgopo Cjedvfe Rcwvuxcgn (oubjdlg Mtu	Rotterdam	The Netherlands
Avlosz Ulvezbsfsc Hfnniwgb	Aarhus	Denmark
Ctouhr Hmkhnvdwms Uwsacqblpnoix Df Pvdav Exvfdd	Porto	Portugal
Uiflcwssoo Op Alryaqt	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.12.2023
Bulgaria	Not recruiting	01.12.2023
Croatia	Recruiting	01.12.2023
Czechia	Recruiting	01.12.2023
Denmark	Recruiting	01.12.2023
Finland	Recruiting	01.12.2023
France	Not yet recruiting	01.12.2023
Germany	Recruiting	01.12.2023
Greece	Recruiting	01.12.2023
Ireland	Recruiting	01.12.2023
Italy	Recruiting	01.12.2023
Lithuania	Recruiting	01.12.2023
Norway	Recruiting	01.12.2023
Poland	Recruiting	01.12.2023
Portugal	Not yet recruiting	01.12.2023
Romania	Recruiting	01.12.2023
Slovakia	Recruiting	01.12.2023
Spain	Recruiting	01.12.2023
Sweden	Recruiting	01.12.2023
The Netherlands	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Roxadustat is a medication being studied for its ability to treat anemia in children and adolescents who have chronic kidney disease. Anemia is a condition where the body does not have enough healthy red blood cells to carry oxygen to the tissues, which can cause fatigue and weakness. Roxadustat works by helping the body produce more red blood cells, which can improve energy levels and overall health in patients with chronic kidney disease. This study aims to understand how well roxadustat works, how safe it is, and how it behaves in the body of pediatric patients.

Anemia associated with Chronic Kidney Disease – This condition occurs when the kidneys, which are responsible for filtering waste from the blood, are damaged and cannot produce enough of a hormone called erythropoietin. This hormone is crucial for the production of red blood cells. As a result, the body has fewer red blood cells, leading to reduced oxygen delivery to tissues and organs. Symptoms may include fatigue, weakness, and shortness of breath. The progression of this anemia is often gradual and correlates with the decline in kidney function. It is commonly seen in individuals with chronic kidney disease, especially in the later stages.

Trial ID:

2022-501980-42-00

Protocol code:

1517-CL-1003

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Roxadustat for Treating Anemia in Children with Chronic Kidney Disease

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