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AnemiaPhase 3NCT05704894

Asses the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood in Childrens

A Phase 3 study testing Erythropoietin in people with Anemia and Neoplasms, run by Blau Farmaceutica S.A..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Anemia is a frequent complication among cancer patients, both as a result of the malignancy of the disease and the aggressiveness of the treatment. Regardless of the degree of anemia, cancer patients produce less erythropoietin (EPO) and, consequently, cannot compensate for the deficit in the production of red blood… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Anemia, Neoplasms, Chemotherapeutic-Induced Anemia
What is being tested?
Erythropoietin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
No sites listed yet
Study dates
May 2023to Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children between 2-17 years old
  • Hemoglobin <12g/dL
  • Solid tumors without bone metastasis
  • Being on current chemotherapy treatment
  • Adequate serum levels of iron, folic acid and Vitamin B12
  • Signature of the Free and Informed Consent Form by the person responsible and Term of Assent by the patient

Who cannot join

  • Refusal to sign the Free and Informed Consent Form and/or Term of assent
  • Estimated survival less than 12 weeks
  • Previous adverse reactions associated with EPO
  • Estar em uso de EPO e inibidores do fator de indução de hipóxia.

Trial locations and contacts

No sites are listed yet.

Blau Farmacêutica contact

114615-9400

pesquisaclinica@blau.com

Research Operations contact

About this study

Official title: Phase III Study, Multi-center, Open, Randomized, to Assess the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood and Improvement of Quality of Life and Fatigue in Children Under Chemotherapy Treatment.

Anemia is a frequent complication among cancer patients, both as a result of the malignancy of the disease and the aggressiveness of the treatment. Regardless of the degree of anemia, cancer patients produce less erythropoietin (EPO) and, consequently, cannot compensate for the deficit in the production of red blood cells, a situation that can worsen in presence of inflammation or infection. In the pediatric oncology population, studies vary in relation to anemia treatment protocols, indications for starting treatment and even there is no robust evidence that treatment with erythropoiesis stimulators results in increased hemoglobin levels, even in mild and moderate anemia, with improvement in quality of life scores and fatigue. Therefore, the proposed study aims to test the efficacy and safety of erythropoietin therapy in the treatment of cancer-related anemia in children and adolescents aged 2 to 17 years. As a secondary objective, to evaluate the benefit of early initiation of EPO (Hb<12g/dL) in children undergoing chemotherapy in improving quality of life and reducing fatigue.

For the evaluation of secondary outcomes, the Student's t test can be applied and analyzes of variance or covariance (ANOVA or ANCOVA) (with treatment group as a factor, and baseline hemoglobin level as a covariate) will be used to compare the outcomes of efficacy defined by variation (change) time point post versus baseline between 2 groups. Adjusted means ("least square means") with 95% CI will be reported. When applicable, secondary outcomes defined by continuous variables evaluated over time (3 or more instants) will be analyzed using mixed model analysis of variance for repeated measures

Being tested
Erythropoietin
Keywords
children, anemia, chemotherapy treatment, quality of life, erythropoietin
Medical subject headings
Anemia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErythropoietinBiological

    Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between <12g/dL

Study groups in NCT05704894
Study groupRoleWhat they receive
Intervention groupExperimentalAdministration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between <12g/dL. Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All assessments, procedures and notes must be recorded in a source document and in a CRF.
Receives: Biological: Erythropoietin
Control GroupNo interventionFor the control group, the procedures will be performed according to the institution's standard treatment (Vitamin B12 and folic acid). The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hemoglobin levels

    Increase of at least 1g/dL in hemoglobin levels within 12 weeks. The main outcome will be described in absolute and relative numbers. 95% Confidence Intervals

    Measured: 12 weeks (from baseline to the level at 12 weeks)

Secondary outcomes (4)

  1. Need for red blood cell transfusion;

    Requirement of blood cell transfusion will be assessed as number of units received on a weekly basis

    Measured: 16 weeks (weekly assessment)

  2. Best Quality of Life Scores;

    We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The POQOLS includes 21 items distributed in three dimensions, which include "physical function and normal activities restriction" (09 items), "emotional problems" (07 items), and "response to active medical treatment" (05 items). Each answer is given on an ordinal scale of 7 points ranging from "never" to "very often". The resulting total score is given on a scale, and higher values mean lower quality of life.

    Measured: 16 weeks (weekly assessment)

  3. Best Scores on the Fatigue Questionnaire;

    We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The PedsQL TM Multidimensional Fatigue Scale items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL Multidimensional Fatigue Scale scores indicate fewer symptoms of fatigue.

    Measured: 16 weeks (weekly assessment)

  4. Analysis of adverse events and side effects associated with medication.

    Adverse events will be monitored from the time the participant gives informed consent and up to 30 days after the last dose of study medication. Adverse events will be classified according to their severity and causality, being reported to the sponsor according to regulatory deadlines.

    Measured: 16 weeks (weekly assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be carried out in approximately 10 participating Brazilian centers. This is a multicenter, open-label, randomized, national study. Randomization will be performed in a 1:1 ratio, in which 160 participants will be allocated to the intervention arm (Erythropoietin 150UI/Kg/week, divided into 3 doses, IV) and 160 participants to the local institution's standard care arm: Iron, Vitamin B12 and Folic Acid. Doses should be prescribed at the physician's discretion. Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All evaluations, procedures and notes must be recorded in a source document and in a CRF (case report form) The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05704894
Sponsor's protocol ID
ERITROBLA1222
Status last verified
Dec 2022
First submitted
8 Dec 2022
Last updated
30 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erythropoietin in people with Anemia and Neoplasms, run by Blau Farmaceutica S.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Blau Farmacêutica (114615-9400, pesquisaclinica@blau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hemoglobin levels (time frame: 12 weeks (from baseline to the level at 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05704894.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

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