A clinical trial to study the effects of two drugs, daprodustat and recombinant human erythropoietin (rhEPO)in Dialysis patients with treatment of anemia associated with chronic kidney disease (CKD)
- Conditions
- Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)Health Condition 2: null- Patients with anemia associated with CKD currently receiving an ESA and with abaseline HemoCue Hgb 8-11.5 g/d
- Registration Number
- CTRI/2017/06/008918
- Lead Sponsor
- GlaxoSmithKline Research Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Age: 18 to 99 years of age (inclusive).
Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
2. Hgb concentration: On randomization (Day 1): Hgb 8 to 11 grams (g)/deciliter (dL) and receiving at least the minimum ESA dose. Hgb more than 11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
3. Dialysis: On dialysis more than 90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
4. Frequency of Dialysis: Hemodialysis (HD) more than equal to 2 times/week and peritoneal dialysis (PD) daily. Home hemodialysis short daily or nocturnal (more than equal to 3x/week).
5. Compliance with placebo [randomization (Day 1) only]: more than equal to 80% and less than equal to 120% compliance with placebo during run-in period.
6. 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.
1. Kidney transplant : Planned living related kidney transplant within 52 weeks after study start (Day 1).
2. Ferritin: less than equal to 100 nanograms (ng) per milliliter (mL) (less than or equal to 100 micrograms per liter [L]) at screening.
3. Transferrin saturation (TSAT) (screening only): less than or equal to 20 per centage.
4. Aplasias: History of bone marrow aplasia or pure red cell aplasia.
5. Other causes of anemia: per nicious anemia thalassemia major sickle cell disease or myelodysplastic syndrome.
6. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric duodenal or esophageal ulcer disease or clinically significant GI bleeding less than or equal to 4 weeks prior to screening through to randomization (Day 1).
7. MI or acute coronary syndrome: less than or equal to 4 weeks prior to screening through to randomization (Day 1).
8. Stroke or transient ischemic attack: less than or equal to 4 weeks prior to screening through to randomization (Day 1).•Heart failure (HF): Chronic Class IV HF as defined by the New York Heart Association (NYHA) functional classification system.
9. Current uncontrolled hy per tension: Current uncontrolled hy per tension as determined by the investigator that would contraindicate the use of recombinant human erythropoietin (rhEPO).
10. Bazetts corrected QT interval (QTcB) (Day 1): QTcB greater than 500 millisecond (msec) or QTcB greater than 530 msec in subjects with bundle branch block. There is no QT Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly paced rhythm.
11. Alanine transaminase (ALT): greater than 2x upper limit of normal (ULN) at screening.
12. Bilirubin: greater than 1.5xULN at screening.
13. Current unstable liver or biliary disease per investigator assessment generally defined by the presence of ascites encephalopathy coagulopathy hypoalbuminaemia esophageal or gastric varices per sistent jaundice or cirrhosis.
14. Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer or complex kidney cyst (example Bosniak Category II F III or IV) greater than 3 centimeter (cm) with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated greater than or equal to 4 weeks prior to screening.
15. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hy per sensitivity to excipients in the investigational product or epoetin alfa or darbepoetin alfa.
16. Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g. gemfibrozil) or strong inducers of CYP2C8 (e.g. rifampin per rifampicin).
17. Prior investigational product exposure: Use of an investigational agent less than or equal to 30 days or within five half lives of the investigational agent (whichever is longer) prior to screening.
18. Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of greater than 30 days.
19. Females only: Subject is pregnant [as confirmed by a positive serum human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only] subject is breastfeeding or subject is of reproductive potential and does not agree to follow one of the contraceptive options listed in the List of Highly Effec
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method