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Clinical Trial 38018

Doral, FL 33122

Study Summary:

A Phase III study will evaluate the safety and the efficacy of daprodustat compared to
darbepoetin alfa for the treatment of anemia associated with CKD in ND subjects. Both
co-primary endpoints must meet non-inferiority of daprodustat to darbepoetin alfa for the
study to be successful and for analyses to progress to testing principal secondary
endpoints. Data from this trial are intended to support the use of daprodustat for the
treatment of anemia associated with CKD in patients not on dialysis.


1. Men or women 18 and older

2. CKD stage (confirm at screening only): Kidney Disease Outcomes Quality
Initiative (KDOQI) CKD stages 3, 4, or 5.

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

4- Week -8 Group 1 not using ESAs - Hgb 8 to 10 g/dL1 (5 to 6.2 mmol/L)
    Group 2 ESA users - Hgb 8 to12 g/dL (5 to 7.5 mmol/L).


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).

3. Ferritin (screening only): ≤100 ng/mL (≤100 g/L).

4. Transferrin saturation (TSAT) (screening only): ≤20%.

Patients MUST meet the criterias indicated in order to be screened. 


Qualified Participants May Receive:

Participant will receive compensation for their time and travel. 

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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.