Clinical trial · Interventional
Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients
A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients
NCT01817699CI-TRIAL-00036919CANDLE-KITterminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The independent Data Monitoring Committee recommended an early termination.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effect of anemia correction and vitamin D supplementation in kidney transplant recipients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Kidney Transplantation | — | UNRESOLVED | — |
| Renal Insufficiency, Chronic | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| High Hb target | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Low Hb target without cholecalciferol
- description
- Target Hemoglobin level: ≥9.5 and \<10.5 g/dL
- type
- ACTIVE_COMPARATOR
- label
- Low Hb target with cholecalciferol
- description
- Target Hemoglobin level: ≥9.5 and \<10.5 g/dL Cholecalciferol: 1,000 IU/day
- interventionNames
- Dietary Supplement: cholecalciferol
- type
- ACTIVE_COMPARATOR
- label
- High Hb target without cholecalciferol
- description
- Target Hemoglobin level: ≥12.5 and \<13.5 g/dL
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * ≥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 Criteria: * 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
References
Publications (5)
- BACKGROUNDChoukroun G, Kamar N, Dussol B, Etienne I, Cassuto-Viguier E, Toupance O, Glowacki F, Moulin B, Lebranchu Y, Touchard G, Jaureguy M, Pallet N, Le Meur Y, Rostaing L, Martinez F; CAPRIT study Investigators. Correction of postkidney transplant anemia reduces progression of allograft nephropathy. J Am Soc Nephrol. 2012 Feb;23(2):360-8. doi: 10.1681/ASN.2011060546. Epub 2011 Dec 22. PMID 22193388
- BACKGROUNDGallagher JC, Sai A, Templin T 2nd, Smith L. Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):425-37. doi: 10.7326/0003-4819-156-6-201203200-00005. PMID 22431675
- BACKGROUNDMatsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A; Collaborators developing the Japanese equation for estimated GFR. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009 Jun;53(6):982-92. doi: 10.1053/j.ajkd.2008.12.034. Epub 2009 Apr 1. PMID 19339088
- BACKGROUNDStevens LA, Schmid CH, Zhang YL, Coresh J, Manzi J, Landis R, Bakoush O, Contreras G, Genuth S, Klintmalm GB, Poggio E, Rossing P, Rule AD, Weir MR, Kusek J, Greene T, Levey AS. Development and validation of GFR-estimating equations using diabetes, transplant and weight. Nephrol Dial Transplant. 2010 Feb;25(2):449-57. doi: 10.1093/ndt/gfp510. Epub 2009 Sep 30. PMID 19793928
- BACKGROUNDHorio M, Imai E, Yasuda Y, Watanabe T, Matsuo S. Modification of the CKD epidemiology collaboration (CKD-EPI) equation for Japanese: accuracy and use for population estimates. Am J Kidney Dis. 2010 Jul;56(1):32-8. doi: 10.1053/j.ajkd.2010.02.344. Epub 2010 Apr 22. PMID 20416999