Last updated: 11/24/2025 05:21:27
Comprehensive Cohort of Anemia in Chronic Kidney Disease (CoCoA-CKD)CoCoA-CKD
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Prospective, Observational, Basket, Comprehensive Cohort Study of Children and Adolescents Aged Less Than 18 Years with Anemia Associated with Chronic Kidney Disease Requiring or Not Requiring Dialysis
Trial description: This is a prospective, international, multicenter, observational cohort study with pediatric participants who have treated, or untreated anemia associated with chronic kidney diseases (CKD) not requiring dialysis (non-dialysis [ND] subpopulation) or dialysis-dependent (dialysis [D] subpopulation). Informed consent will also include for a retrospective review of a participant’s medical records for up to the 12 months preceding study entry, as well as consent to approach for an interventional trial (GSK study identification number: 214066) should they be selected.Participants will be followed prospectively for a goal of up to 36 months, with study visits every 3 months.There is no study intervention being assessed in this prospective observational cohort study. However, should a participant commence erythropoiesis stimulating agent (ESA) therapy as part of standard of care (SoC) during the course of the study, an extra hemoglobin (Hgb) visit should be undertaken at 4 and 8 weeks post commencement of the ESA, to assess the Hgb response to treatment, as well as for any adverse events (AEs).
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean Hemoglobin (Hgb) value
Timeframe: Up to 36 months
Mean change from baseline (Day 1) in Hgb values
Timeframe: Baseline (Day 1) and up to 36 months
Number of participants with Hgb values above, below, and within range of 10 to 12 g/dL
Timeframe: Up to 36 months
Mean Hgb Value at the Time of ESA Initiation for ESA-naïve participants
Timeframe: Up to 36 months
Mean Hgb Value 4 Weeks After ESA Initiation for ESA-naïve participants
Timeframe: Up to 36 months
Mean Hgb Value 8 Weeks After ESA Initiation for ESA-naïve participants
Timeframe: Up to 36 months
Secondary outcomes:
Number of Participants ESA Usage Overall and Using Different Types of ESA During the Study
Timeframe: Up to 36 months
Mean ESA Dose Overall and Standardized ESA Dose at each study timepoint
Timeframe: Up to 36 months
Mean ESA Dose Changes from Baseline (Day 1) at each study timepoint
Timeframe: Baseline (Day 1) and Up to 36 months
Number of Participants Initiating ESA During the Study
Timeframe: Up to 36 months
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 36 months
Number of participants with adverse event of special interests (AESIs)
Timeframe: Up to 36 months
Number of participants with AEs leading to discontinuation of ESA SoC therapy
Timeframe: Up to 36 months
Number of participants with change from baseline in laboratory safety parameters
Timeframe: Baseline (Day 1) and Up to 36 months
Mean change from baseline in blood pressure (BP)
Timeframe: Baseline (Day 1) and Up to 36 months
Mean change from baseline in heart rate (HR)
Timeframe: Baseline (Day 1) and Up to 36 months
Mean change from baseline in weight
Timeframe: Baseline (Day 1) and Up to 36 months
Mean change from baseline in height
Timeframe: Baseline (Day 1) and Up to 36 months
Interventions:
Not applicable
Enrollment:
234
Primary completion date:
2024-22-10
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Anaemia
Product
daprodustat
Collaborators
Not applicable
Study date(s)
March 2023 to October 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 17 Years
Accepts healthy volunteers
No
- Participant must be less than (<)18 years of age at the time of signing the informed
- consent.
- Kidney transplant recipient with a functioning allograft.
- Scheduled for elective kidney transplantation within 3 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant must be less than (<)18 years of age at the time of signing the informed consent.
- Anemia associated with CKD stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent CKD, defined as receiving treatment for anemia with an erythropoiesis stimulating agent (ESA) or have a Hgb ≤12.0 g/dL in ESA non-users.
- Written informed consent or assent as appropriate.
Exclusion criteria:
- Kidney transplant recipient with a functioning allograft.
- Scheduled for elective kidney transplantation within 3 months.
- History of bone marrow aplasia or pure red cell aplasia.
- Other causes of anemia.
- Active or previous malignancy within the last 2 years.
- Acute or chronic infection requiring antimicrobial therapy.
- Cirrhosis or current unstable liver or biliary disease.
- Participation in a clinical study with a study intervention under evaluation to treatment anemia of CKD or anticipated to confound the interpretation of the Hgb.
- Participants receiving a hypoxia inducible factor prolyl hydroxylase inhibitor (HIF-PHI), whether licensed or within a clinical trial.
Trial location(s)
Showing 1 - 6 of 12 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-22-10
Actual study completion date
2024-22-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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