Clinical Trials List
2016-12-01 - 2020-12-31
Phase III
Terminated12
ICD-10Y84.1
Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
ICD-10N18.9
Chronic kidney disease, unspecified
ICD-10N18.6
End stage renal disease
ICD-9E879.1
Kidney dialysis, without mention of misadventure at the time of procedure, as the cause of abnormal reaction of patient, or of later complication
ASCEND-D: A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents
-
Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
-
Sponsor
GlaxoSmithKline Research & Development Limited
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 曾進忠 Division of Nephrology
- Wei-Hung Lin Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊紹佑 Division of Nephrology
- SHUEI-LIONG LIN Division of Nephrology
- VIN-CENT Wu Division of Nephrology
- 高芷華 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tso-Hsiao Chen Division of Nephrology
- Chung-Yi Cheng Division of Nephrology
- Yen-Cheng Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Cai-Mei Zheng Division of Nephrology
- Mei-Yi Wu Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yi wen chiu Division of Nephrology
- Shang-Jyh Hwang Division of Nephrology
- 郭美娟 Division of Nephrology
- 郭弘典 Division of Nephrology
- 洪啟智 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Guan-Hsing Chen Division of Nephrology
- 翁正昊 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊智宇 Division of Nephrology
- Yao-Ping Lin Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
(composite of all-cause mortality, non-fatal MI
and non-fatal stroke)
• Mean change in Hgb between baseline and EP
(mean over Weeks 28 to 52)
• Time to first occurrence of adjudicated
• MACE
• MACE or a thromboembolic event (vascular
access thrombosis, symptomatic deep vein
thrombosis or symptomatic pulmonary
embolism)
• MACE or a hospitalization for heart failure
(HF)
• Average monthly IV iron dose (mg)/subject to
Week 52
Inclution Criteria
2. ESAs: Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
3. Hgb concentration measured by HemoCue (range is inclusive):
Week -8:
- Hgb 8 to 12 g/dL1 (5 to 7.4 mmol/L).
Day 1:
- Hgb 8 to 11 g/dL (5 to 6.8 mmol/L) and receiving at least the minimum ESA dose2.
- Hgb >11 g/dL to 11.5 g/dL (6.8 mmol/L to 7.1 mmol/L) and receiving greater than the minimum ESA dose2.
4. Dialysis: On dialysis >90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
5. Frequency of Dialysis:
• HD: ≥2 times/wk
• PD: at least five times a week
• Home HD: short daily or nocturnal (≥2x/week)
6. Compliance with placebo [randomization (Day 1) only]: ≥80% and ≤120% compliance with placebo during run-in period (NOTE: this is in addition to ESA treatment).
7. 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.
Exclusion Criteria
Anemia related criteria
2. Ferritin (screening only): ≤100 ng/mL (≤100 g/L).
3. Transferrin saturation (TSAT) (screening only): ≤20%.If TSAT is 18-20%, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20% to confirm eligibility.
4. Aplasias: History of bone marrow aplasia or pure red cell aplasia.
5. Other causes of anemia: Untreated Pernicious 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 ≤4 weeks prior to screening through to randomization (Day 1).
CV disease-related criteria
7. MI or acute coronary syndrome: ≤4 weeks prior to screening through to randomization (Day 1).
8. Stroke or transient ischemic attack: ≤4 weeks prior to screening through to randomization (Day 1).
9. Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
10. Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.
11. 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
12. 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.
13. 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
14. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (refer to daprodustat IB), or epoetin alfa or darbepoetin alfa (refer to product labeling).
15. Drugs and supplements Use of strong inhibitors of CYP2C8 (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
16. Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1).
• Note: at screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer).
17. Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of >30 days.
The Estimated Number of Participants
-
Taiwan
93 participants
-
Global
3000 participants
