Status:
TERMINATED
Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients
Lead Sponsor:
CANDLE-KIT Trial Study Group
Collaborating Sponsors:
Chugai Pharmaceutical
Japanese Society for the Promotion of Science
Conditions:
Kidney Transplantation
Anemia
Eligibility:
All Genders
20-79 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effect of anemia correction and vitamin D supplementation in kidney transplant recipients.
Detailed Description
Sample size estimation: The previous trial (the CAPRIT study) showed that 2.0 g/dL increase of hemoglobin (Hb) reduced 69% of 2-year decline in estimated glomerular filtration rate (eGFR) (Choukroun ...
Eligibility Criteria
Inclusion
- ≥15 and \<60 ml/min per 1.73 m2 of estimated glomerular filtration rate
- Transplanted allograft kidney at least 1 year before
- \<10.5 g/dL of Hb without iron deficiency (serum ferritin level ≥50 ng/ml) or on erythropoiesis stimulating agents treatment regardless of iron status
- With written informed consent
Exclusion
- On anticancer treatment
- History of ischemic stroke or transient ischemic attack
- Corrected serum calcium ≥10.5 mg/dL
- HIV virus infection
- Anticipated refractory hypertension by using epoetin beta pegol
- In pregnancy and lactation
- Current use of native vitamin D supplement
- Patients ineligible according to the investigator's judgement
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01817699
Start Date
April 1 2013
End Date
December 1 2018
Last Update
February 4 2019
Active Locations (1)
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1
CANDLE Trial Study Group
Suita, Osaka, Japan, 565-0871