Anemia associated with chronic kidney disease MedDRA version: 19.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply at screening and randomization (Day 1) unless otherwise specified. 1. Age (confirm at screening): 18 to 99 years of age inclusive 2. Dialysis: Planning to start chronic dialysis within the next 4 weeks (from the date of the screening visit) OR have started and received dialysis (as specified below) for end-stage renal disease for a maximum of =90 days immediately prior to randomization and is not expected to stop dialysis during the duration of the trial: - HD = 2X/week, or - Daily PD (Including continuous and automated PD) 3. Hemoglobin concentration as measured by HemoCue (range inclusive): 8-10.5 g/dL (5-6.5 mmol/L) at screening and 8-11.0 g/dL (5-6.8 mmol/L) at randomization 4. Informed consent: capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol Note: The country-specific requirements for France ONLY for the informed consent process is provided in Appendix 11 (see Section 12.11.1, Item 3 for details) 5. Other study eligibility criteria considerations: The country-specific requirements for France ONLY for the eligibility for inclusion in this study is provided in Appendix 11 (see Section 12.11.1, Item 1 for details) 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 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: A subject will not be eligible for participation in this study if any of the following criteria apply at screening or at randomization (Day 1), unless otherwise specified. CKD-related criteria 1. Kidney transplant: Planned living-related donor kidney transplant during the study. Anemia related criteria 2. Ferritin: =100 ng/mL (=100 µg/L) at screening or after IV iron supplementation. 3. TSAT: =20% at screening or after IV iron supplementation. 4. Vitamin B12: Below the lower limit of the reference range at screening or after vitamin B12 supplementation 5. Folate: 500 msec, or QTcB >530 msec in subjects with bundle branch block. There is no QTc exclusion for subjects with a predominantly paced rhythm Other disease-related criteria 15. Liver disease (any one of the following): - Alanine transaminase (ALT) >2x upper limit of normal (ULN) (screening only) - Bilirubin >1.5xULN (screening only) NOTE: Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 3cm. The only exception is localized squamous cell or basal cell carcinoma of the skin that has been definitively treated =10 weeks prior to screening. Concomitant medications and other study treatment-related criteria 17. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (refer to daprodustat IB) or to da
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare daprodustat to rhEPO for Hgb efficacy (non-inferiority);Secondary Objective: To compare daprodustat to rhEPO on the use of intravenous (IV) iron;Primary end point(s): Mean change in Hgb between baseline and evaluation period (EP, mean over Weeks 28-52);Timepoint(s) of evaluation of this end point: Between week 28 and week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Average monthly IV iron dose (mg)/subject from baseline to Week 52;Timepoint(s) of evaluation of this end point: Between baseline and Week 52 | — |
Countries
Argentina, Australia, Brazil, Canada, France, Germany, India, Italy, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed