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 range19 Years

SexALL

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
✕. Patients who had hypersensitivity to erythropoietin agents
✕. Patients who had known hypersensitivity to mammalian cell-derived products or additives
✕. Patients with history of severe cardiovascular diseases
✕. Patients whose anemia is not caused by chronic renal failure or may affect anemia correction including the following conditions:

What they're measuring

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])

Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24

Timeframe: Weeks 20 - 24

Trial details

NCT IDNCT03431623

SponsorChong Kun Dang Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02

View on ClinicalTrials.gov More Anemia of Chronic Kidney Disease trials