Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients (CANDLE-KIT): a Multicenter, 2x2 Factorial, Open-label, Randomized Clinical Trial.
Obi, Y., et al.Transplant International 2021 [record in progress].
Aims
This study aimed to investigate the effect of anemia correction and cholecalciferol supplementation in the preservation of kidney function among kidney transplant recipients.
Interventions
Patients were randomised to either a high haemoglobin target or a low haemoglobin target, and then to either the cholecalciferol group or the control group.
Participants
153 kidney transplant recipients.
Outcomes
The primary endpoint was change in creatinine-based eGFR (eGFRcr). The secondary endpoints were methoxy polyethylene glycol epoetin beta (MPG-EPO) dose, patient death (all-causes), cancer development or recurrence, blood pressure, acute cellular rejection (biopsy-proven), renal composite outcome consisting of 50% increase in serum creatinine, re-initiation of dialysis and subsequent transplantation.
Follow-up
2 years
CET Conclusions
This is a well-written report of an interesting and well-conducted study. It is an open-label multicentre RCT in renal transplantation. Patients at least one year after transplant were randomised to a high or low haemoglobin target (>12.5g/dL versus <10.5g/dL), and also to receive cholecalciferol or control. Randomisation was done by a computerised system, stratified by time since transplant and urine protein: creatinine ratio. The primary outcome was change in estimated GFR over the 2-year follow up. The study was terminated early on the basis of the interim analysis, which showed a significantly smaller drop in GFR in the high haemoglobin group. The change in estimated GFR was not related to the use of cholecalciferol in this analysis.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT01817699; UMIN000009970