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

Phase 4

Recruiting

• Conditions: cardiovascular events, stroke, myocardial infarction, leg amputation, admission by heart failure or angina.

• Registration Number: TCTR20190718006
• Lead Sponsor: Department of Nephrology Unit Faculty of Medicine Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-18
• Study Completion: 2020-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite renal outcome of starting dialysis 52 week stratification factors

Secondary Outcome Measures

Name	Time	Method
Time from enrollment to initiation of dialysis 52 week time-to-event