Clinical Trials List
2016-12-01 - 2021-11-30
Phase III
Recruiting7
Terminated5
ICD-9583.89
Nephritis and nephropathy, not specified as acute or chronic, with other specified pathological lesion in kidney
A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa
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Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
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Sponsor
GlaxoSmithKline Research & Development Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 曾進忠 Division of Nephrology
- Wei-Hung Lin Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tso-Hsiao Chen Division of Nephrology
- Yen-Cheng Chen Division of Nephrology
- Chung-Yi Cheng Division of Nephrology
The Actual Total Number of Participants Enrolled
4 Recruiting
Audit
None
Co-Principal Investigator
- 郭弘典 Division of Nephrology
- Shang-Jyh Hwang Division of Nephrology
- Yi wen chiu Division of Nephrology
- 郭美娟 Division of Nephrology
- 洪啟智 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 翁正昊 Division of Nephrology
- Guan-Hsing Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 許恆榮 Division of Nephrology
- Chun-Yu Chen Division of Nephrology
- 李進昌 Division of Nephrology
- 孫樵隱 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 楊智宇 Division of Nephrology
- Yao-Ping Lin Division of Nephrology
- Wei-Cheng Tseng Division of Nephrology
- 歐朔銘 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Mean change in Hgb between baseline and EP (mean over Weeks 28 to 52)
Inclution Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria
apply at screening (Week -8) and randomization (Day 1), unless otherwise specified.
1. Age (confirm at screening only): 18 to 99 years of age (inclusive).
2. CKD stage (confirm at screening only): Kidney Disease Outcomes Quality
Initiative (KDOQI) CKD stages 3, 4, or 5 defined by eGFR using the CKD
Epidemiology Collaboration (CKD-EPI) formula [Levey, 2009]
3. ESAs:
Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and
no ESA use between screening and randomization (Day 1).
Group 2 (ESA users): Use of any approved ESA (see footnote in table below) for
the 6 weeks prior to screening and continuing between screening and
randomization.
4. HemoCue Hgb (range inclusive)
5. Compliance with placebo [randomization (Day 1) only]: ≥80% and ≤120%
compliance with placebo during run-in period (NOTE: for ESA users, this is in
addition to ESA treatment).
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.
Note: The country-specific requirements for France ONLY for the informed consent
process are provided in Appendix 15 (see Section 12.15.1 Item 3 for details).
7. Other study eligibility criteria considerations: The country-specific requirements
for France ONLY for inclusion in this study are provided in Appendix 15
Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria
apply at screening (Week -8) and randomization (Day 1), unless otherwise specified.
CKD related criteria
1. Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis
within 90 days after study start (Day 1).
2. Kidney transplant: Planned living-related kidney transplant within 52 weeks after
study start (Day 1).
Anemia-related criteria
3. Ferritin (screening only): ≤100 ng/mL (≤100 g/L).
4. Transferrin saturation (TSAT) (screening only): ≤20%.
5. Aplasias: History of bone marrow aplasia or pure red cell aplasia.
6. Other causes of anemia: Pernicious anemia, thalassemia major, sickle cell disease
or myelodysplastic syndrome.
7. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or
esophageal ulcer disease OR clinically significant GI bleeding ≤4 weeks prior to
screening through to randomization (Day 1).
CV disease-related criteria
8. MI or acute coronary syndrome: ≤4 weeks prior to screening through to
randomization (Day 1).
9. Stroke or transient ischemic attack: ≤4 weeks prior to screening through to
randomization (Day 1).
10. Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart
Association (NYHA) functional classification system.
11. Current uncontrolled hypertension: Current uncontrolled hypertension as
determined by the investigator that would contraindicate the use of rhEPO.
12. 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 paced
rhythm.
Other disease-related criteria
13. 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 <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) are acceptable if subject otherwise meets
entry criteria.
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 (e.g. Bosniak Category II F, III or IV) > 3cm. Note: The only exception
is localized squamous cell or basal cell carcinoma of the skin that has been
definitively treated 4 weeks prior to screening.
Concomitant medication and other randomized treatment-related criteria
15. Severe allergic reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product (refer to daprodustat IB)
or darbepoetin alfa (refer to product labeling).
16. Drugs and supplements: Use of strong inhibitors of CYP2C8 (e.g., gemfibrozil) or
strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
17. Prior investigational product exposure: Use of an investigational agent ≤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 a
treatment duration of >30 days.
General health-related criteria
19. Females ONLY: Subject is pregnant [as confirmed by a positive urine 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 Effective
Methods for Avoiding Pregnancy in Appendix 5.
Note: See Section 12.15.2 for the country-specific requirements for the Czech
Republic ONLY relating to acceptable contraceptive methods during participation in
this study.
20. Other Conditions: Any other condition, clinical or laboratory abnormality, or
examination finding that the investigator considers would put the subject at
unacceptable risk, which may affect study compliance (e.g., intolerance to
darbepoetin alfa) or prevent understanding of the aims or investigational procedures
or possible consequences of the study.
The Estimated Number of Participants
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Taiwan
135 participants
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Global
4500 participants
