CKD-11101 Phase 3 SC Study (NCT03431623) | Clinical Trial Compass
CompletedPhase 3
CKD-11101 Phase 3 SC Study
248 participantsStarted 2015-05
Plain-language summary
The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with 19 years of age or older
. Patients with chronic renal failure of stage 3 or above who are not on dialysis
. Patients with the Hb levels of 8 to 10g/dl measured at screening
. Patients with enough body iron stores who meet the following item:
Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
. Patients who have provided written consent to participate in the clinical trial voluntarily
Exclusion criteria
. Patients who are expected to need dialysis within a year or patients with rapidly progressive chronic renal failure
. Patients who have received drug treatment such as erythropoiesis stimulating agent for the purpose of correcting anemia within 12 weeks prior to screening
. Patients who have received red blood cell transfusion within 12 weeks prior to screening
. Patients with uncontrolled hypertension
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changed amount of mean hemoglobin level in evaluation period compared to the baseline
Timeframe: ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])
2
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24