Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat- in Incident Dialysis (ASCEND-ID)
- Conditions
- Anemia associated with chronic kidney diseaseMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2016-000507-86-IT
- Lead Sponsor
- GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 300
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 6 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
- PD (<= 4times/week including incremental schedule; subjects on continuous ambulatory peritoneal dialysis /CAPD) and automated peritoneal dialysis (APD) are eligible)
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 (at screening): 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
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 or living-unrelated 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: <2.0 ng/mL (<4.5 nmol/ L) at screening
6. Aplasias: History of bone marrow aplasia or pure red cell aplasia (PRCA).
7. Other causes of anemia: Untreated pernicious anemia, thalassemia major, sickle cell disease, or myelodysplastic syndrome.
8. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding =10 weeks prior to screening through to radomization (Day 1).
Erythropoiesis treatment criteria
9. Use of any ESA treatment within 8 weeks prior to screening except for limited use as part of dialysis initiation. Limited use is defined as no more than 6 weeks of short acting ESA (rhEPO or biosimilars; maximum of 20000 U total) or long acting ESA (darbepoetin alfa [maximum of 100 µg total] or methoxy polyethylene glycol-epoetin beta [maximum of 125 µg total]) received before or after starting dialysis.
Cardiovascular disease-related criteria
10. Myocardial infarction or acute coronary syndrome: =10 weeks prior to screening through to randomization (Day 1).
11. Stroke or transient ischemic attack: =10 weeks prior to screening through to randomization (Day 1).
12. Heart failure: Chronic Class IV heart failure, as defined by the New York HeartAssociation (NYHA) functional classification system.
13. Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of rhEPO.
14. QTcB (Day 1): QTcB >500 msec, or QTcB >530 msec in subjects with bundle branch block. There is no QTc exclusion for subjects with a predominantly ventricular paced rhythm
Other disease-related criteria
Please see protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare daprodustat to rhEPO for Hgb efficacy<br>(non-inferiority);Secondary Objective: To compare daprodustat to rhEPO on the use of<br>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 Outcome Measures
Name Time Method 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