Anemia associated with chronic kidney disease (CKD) MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Daprodustat
Product Code: [GSK1278863]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DAPRODUSTAT
CAS Number: 960539-70-2
Current Sponsor code: GSK1278863A (A denotes the f
Sponsors
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 3 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Kidney transplant recipient with a functioning allograft. 2. Scheduled for elective kidney transplantation within 3 months. 3. Iron deficiency, defined as: - Transferrin saturation (TSAT) 480 msec, or • QT interval corrected for heart rate (QTc) >500 msec in participants with bundle branch block. 14. Liver abnormality/disease as described in the protocol. 15. Participants who have previously received treatment with any HIFPHI, including daprodustat within the last 30 days. 16. Participants who have previously failed to respond to treatment with daprodustat or any other HIF-PHI. 17. Participants, who have received within the last 7 days, or anticipate receiving during the study, strong inhibitors of CYP2C8 (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin). 18. Other investigational product/clinical study: Participants who have received treatment with an investigational agent (biologic or non biologic) within the past 30 days or 5 drug half-lives whichever is longer, with the exception of treatments or vaccines for SARS-CoV-2 with provisional or emergency approval. 19. Participants who are currently participating in any other clinical study of an investigational medicinal product (IMP). 20. Participants with any history of hypersensitivity to daprodustat or its excipients, or to any other HIF-PHI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary (Safety): Describe the safety of daprodustat, overall (all ages) and in each age group;Secondary Objective: Secondary Safety: Describe changes in other parameters relevant to safety, overall and in each age group. Secondary Efficacy: - Describe the effect of daprodustat on Hgb, overall and in each age group (and additionally overall in all ages by ESA use [yes/no] at study enrollment). - Describe the change in required dose over time, in each age group. Secondary Pharmacokinetic: - Characterize the PK of daprodustat in each age group. - Describe the systemic exposure to daprodustat metabolites, M2, M3, M4, M5, M6 and M13 in each age group.;Primary end point(s): Primary (Safety): Incidence of AEs, Serious Adverse Events (SAEs), AESIs, and AEs leading to study intervention discontinuation.;Timepoint(s) of evaluation of this end point: AE/SAE assessment: From Screening (-4 weeks to Day 1) to Follow-up (week 56) | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trials Help Desk
GlaxoSmithKline Research & Development Limited
Outcome results
None listed