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Correcting anemia and native vitamin D supplementation in kidney transplant recipients: a multicenter, 2 × 2 factorial, open-label, randomized clinical trial.
- Source :
-
Transplant international : official journal of the European Society for Organ Transplantation [Transpl Int] 2021 Jul; Vol. 34 (7), pp. 1212-1225. Date of Electronic Publication: 2021 Jun 15. - Publication Year :
- 2021
-
Abstract
- Anemia and vitamin D deficiency are associated with allograft failure, and hence, are potential therapeutic targets among kidney transplant recipients (KTRs). We conducted a multicenter, two-by-two factorial, open-label, randomized clinical trial to examine the effects of anemia correction and vitamin D supplementation on 2-year change in eGFR among KTRs (CANDLE-KIT). We enrolled 153 patients with anemia and >1-year history of transplantation across 23 facilities in Japan, and randomly assigned them to either a high or low hemoglobin target (>12.5 vs. <10.5 g/dl) and to either cholecalciferol 1000 IU/day or control. This trial was terminated early based on the planned interim intention-to-treat analyses (α = 0.034). Among 125 patients who completed the study, 2-year decline in eGFR was smaller in the high vs. low hemoglobin group (i.e., -1.6 ± 4.5 vs. -4.0 ± 6.9 ml/min/1.73 m <superscript>2</superscript> ; P = 0.021), but did not differ between the cholecalciferol and control groups. These findings were supported by the fully adjusted mixed effects model evaluating the rate of eGFR decline among all 153 participants. There were no significant between-group differences in all-cause death or the renal composite outcome in either arm. In conclusion, aggressive anemia correction showed a potential to preserve allograft kidney function.<br /> (© 2021 Steunstichting ESOT. Published by John Wiley & Sons Ltd.)
- Subjects :
- Dietary Supplements
Humans
Japan
Vitamin D
Anemia drug therapy
Kidney Transplantation
Subjects
Details
- Language :
- English
- ISSN :
- 1432-2277
- Volume :
- 34
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Transplant international : official journal of the European Society for Organ Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 33884674
- Full Text :
- https://doi.org/10.1111/tri.13885