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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190718006

Enrollment

Unknown

Registered

2019-07-18

Start date

2019-03-19

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular events&#44

Interventions

100 subjects (Hb <10.0 g/dL) randomized to the treatment arm will receive Mircera 75 ug SC monthly to maintain Hb between 10.5 &#45

11.5 g/dl,100 subjects (Hb <10.0 g/dL) randomized to the control arm will not receive any treatment to keep target 8.5 &#45

9.5 g/dL.

Active Comparator Drug,No Intervention No treatment

Treatment arm,Control arm

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Composite renal outcome of starting dialysis 52 week stratification factors	—

Secondary

Measure	Time frame
Time from enrollment to initiation of dialysis 52 week time-to-event	—

Countries

Thailand

Contacts

Public ContactProf.Kearkiat Praditpornsilpa

Faculty of Medicine, Chulalongkorn University

kearkiat@hotmail.com0867701059

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

A RANDOMIZED&#44; CONTROLLED&#44; OPEN&#45;LABEL&#44; SINGLE&#45;CENTER&#44; PARALLEL GROUP STUDY TO ASSESS THE EFFECT OF MIRCERA ON DELAYING DIALYSIS IN ANEMIC PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE NOT ON DIALYSIS