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Clinical Trials/TCTR20190718006
TCTR20190718006RecruitingPhase 4

A RANDOMIZED, CONTROLLED, OPEN-LABEL, SINGLE-CENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFECT OF MIRCERA ON DELAYING DIALYSIS IN ANEMIC PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE NOT ON DIALYSIS

Department of Nephrology Unit Faculty of Medicine Chulalongkorn University0 sites200 target enrollmentStarted: July 18, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
200
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to 80 Years (—)
Sex
All

Inclusion Criteria

  • •1. CKD patients who are not on dialysis
  • •2. eGFR 8 and more and less than 15 mL/min/1.73m2 determined twice in last 12 weeks.
  • •3. CKD patients with renal anemia at Hb less than 10 g/dL in screening
  • •4. CKD patients with TSAT 20% and higher or serum ferritin 100ng/mL and higher.
  • •5. CKD patients treated with standard care
  • •6. CKD patients provided written informed consent.

Exclusion Criteria

  • •. Uncontrolled hypertension (180/100 mmHg and higher)
  • •2. Heart failure (NYHA III and IV)
  • •3. Malignancy, hematological disorder
  • •4. Malnutrition
  • •5. Active and continuous gastrointestinal tract bleeding
  • •6. Planned kidney transplant within 6 months
  • •7. Myocardial infarction within last 6 months
  • •8. Stroke or pulmonary embolism within last 12 months
  • •9. Pregnant women, women on lactation, or CKD patients who plan to get pregnant
  • •10. Allergy against erythropoietin

Investigators

Sponsor
Department of Nephrology Unit Faculty of Medicine Chulalongkorn University

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