Anaemia associated with chronic kidney disease
Conditions
Sponsors
GlaxoSmithKline, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 1. =18 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. CKD: Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI formula [Levey, 2009]. 3. Hgb: Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1) (Section 9.1 of the study protocol). 4. IV Iron: Participants may receive up to one IV iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1). 5. Oral Iron: If needed, participant may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1). Sex 6. Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant (see Section 12.4), not breastfeeding, and at leastone of the following conditions applies: Not a woman of childbearing potential (WOCBP) as defined in Section 12.4 (Appendix 4) of the study protocol, or A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 of the study protocol during the treatment period and for at least 4 weeks after the last dose of study treatment. Informed Consent 7. Capable of giving signed informed consent as described in Section 12.2 Appendix 2 of the study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: CKD Related Criteria 1. Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1). 2. Kidney Transplant: Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1). Anemia-Related Criteria 3. Transferrin saturation (TSAT) 30 days. Cardiovascular Disease-Related Criteria 15. MI or acute coronary syndrome: within the 8 weeks prior to screening through to randomization. (Day 1) 16. Stroke or transient ischemic attack: within the 8 weeks prior to screening through to randomization. (Day 1) 17. Heart failure: Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system 18. QTcB (Day 1): QTcB >500 msec or QTcB >530 msec in participants with bundle branch block. There is no QTc exclusion for participants with a predominantly paced rhythm. Other Disease Related Criteria 19. Liver Disease-Related Criteria: - Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening(Week -4). - Bilirubin >1.5xULN at screening (Week -4). NOTE: Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%. - Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable chronic liver disease (including asymptomatic gallstones, chronic hepatitis B or C, or Gilbert’s syndrome) is acceptable if participant otherwise meets entry criteria. 20. Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer,
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): % of participants having a Hgb increase of =1.0 g/dL from baseline to EP. Mean Change in SF-36 Vitality domain between baseline and Week 28;Timepoint(s) of evaluation of this end point: 1. from baseline at any post-baseline visit. 2. between baseline and Week 28 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of daprodustat to placebo on mean change in Hgb levels;Secondary Objective: To compare the proportion of participants achieving increases in Hgb when treated with daprodustat versus placebo. To compare daprodustat to placebo for health related quality-of-life;Primary end point(s): Mean change in Hgb between baseline and the Evaluation Period (EP, mean over week 24 to week 28 inclusive);Timepoint(s) of evaluation of this end point: Evaluation period is mean over week 24 to week 28 inclusive. | — |
Countries
Argentina, Australia, Brazil, Canada, France, Italy, Korea, Republic of, Mexico, Poland, Romania, Spain, United Kingdom, United States
Contacts
Public ContactCentro de Información
GlaxoSmithKline
Outcome results
None listed