A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial

A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial - Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009970

Enrollment

272

Registered

2013-02-06

Start date

2013-04-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Kidney transplantation

Interventions

Conventional anemia management (Target Hb &gt

=9.5 and &lt

10.5 g/dL) with cholecalciferol (1,000 IU/day) Conventional anemia management (Target Hb &gt

10.5 g/dL) without cholecalciferol Aggressive anemia correction (Target Hb &gt

=12.5 and &lt

13.5 g/dL) with cholecalciferol (1,000 IU/day) Aggressive anemia correction (Target Hb &gt

13.5 g/dL) without cholecalciferol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) >=15 and <60 ml/min per 1.73 m2 of estimated glomerular filtration rate 2) Transplanted allograft kidney at least 1 year before 3) <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 4) With written informed consent

Exclusion criteria

Exclusion criteria: 1) On anticancer treatment 2) History of ischemic stroke or transient ischemic attack 3) Corrected serum calcium >=10.5 mg/dL 4) HIV virus infection 5) Anticipated refractory hypertension by using epoetin beta pegol 6) In pregnancy and lactation 7) Current use of native vitamin D supplement 8) Patients ineligible according to the investigator's judgement

Design outcomes

Primary

Measure	Time frame
Change in estimated glomerular filtration rate	—

Secondary

Measure	Time frame
- Urine markers of kidney injury at 6 months 1) L-FABP 2) NGAL 3) TGF-beta 4) Protein-creatinine ratio - The dose of epoetin beta pegol required to maintain the target hemoglobin level - C-reactive protein - Change in blood pressure - Cardiac biomarkers 1) BNP 2) Cardiac troponin-T - left-ventricular mass index - Biopsy-proven acute cellular rejection - Bone-turnover markers 1) 1-84 PTH 2) Bone-type alkaline phosphatase 3) tartrate-resistant acid phosphatase 5b (TRACP-5b) - Bone mineral density of lumber spine and femoral neck. - Hypercalcemia (Corrected calcium >=11 mg/dL) - Event-free survival for the following endpoints 1) Renal composite endpoint (50% increase in serum creatinine, subsequent transplantation, and reinitiation of dialysis) 2) Admission-required cardiovascular events (myocardial infarction, angina, congestive heart failure, stroke, and peripheral artery disease) 3) All-cause death 4) Cancer development or recurrence 5) Infections requiring hospitalization (e.g., Polyomavirus-associated nephropathy, tuberculosis, Pneumocystis carinii pneumonia, cytomegalovirus infection, herpes zoster, bacterial pneumonia)	—

Measure

Time frame

- Urine markers of kidney injury at 6 months 1) L-FABP 2) NGAL 3) TGF-beta 4) Protein-creatinine ratio - The dose of epoetin beta pegol required to maintain the target hemoglobin level - C-reactive protein - Change in blood pressure - Cardiac biomarkers 1) BNP 2) Cardiac troponin-T - left-ventricular mass index - Biopsy-proven acute cellular rejection - Bone-turnover markers 1) 1-84 PTH 2) Bone-type alkaline phosphatase 3) tartrate-resistant acid phosphatase 5b (TRACP-5b) - Bone mineral density of lumber spine and femoral neck. - Hypercalcemia (Corrected calcium >=11 mg/dL) - Event-free survival for the following endpoints 1) Renal composite endpoint (50% increase in serum creatinine, subsequent transplantation, and reinitiation of dialysis) 2) Admission-required cardiovascular events (myocardial infarction, angina, congestive heart failure, stroke, and peripheral artery disease) 3) All-cause death 4) Cancer development or recurrence 5) Infections requiring hospitalization (e.g., Polyomavirus-associated nephropathy, tuberculosis, Pneumocystis carinii pneumonia, cytomegalovirus infection, herpes zoster, bacterial pneumonia)

—

Countries

Japan

Contacts

Public ContactYoshitsugu Obi

Osaka University Graduate School of Medicine Department of Nephrology

y-obi@kid.med.osaka-u.ac.jp06-6879-3857

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026