Last updated: 10/15/2025 08:20:13
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
Recruitment complete
Recruitment 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 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
Number of participants who will initiate erythropoiesis-stimulating agent (ESA) therapy for the first time during the study
Timeframe: Up to 36 months
Mean Hgb value at the time of ESA initiation
Timeframe: Up to 36 months
Mean Hgb value 4 weeks after ESA initiation
Timeframe: Up to 36 months
Mean Hgb value 8 weeks after ESA initiation
Timeframe: Up to 36 months
Secondary outcomes:
Number of participants who used ESA during the study
Timeframe: Up to 36 months
Mean overall and standardized ESA dose
Timeframe: Up to 36 months
Mean ESA dose changes from baseline
Timeframe: Baseline (Day 1) and Up to 36 months
Number of participants using different types of ESA
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.
- 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.
- 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.
- 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.
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
Recruitment complete
Actual primary completion date
2024-22-10
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website