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Published on: June 2, 2022
Dialysate calcium, alfacalcidol, and clinical outcomes: A post-hoc analysis of the J-DAVID trial
Kunitoshi Iseki1, Daijiro Kabata2, Tetsuo Shoji3,4
1Nakamura Clinic, Urasoe, Okinawa, Japan.
Insights
Dialysate calcium concentration (D-Ca) did not significantly alter the cardiovascular benefits of oral alfacalcidol in chronic hemodialysis patients. This finding impacts treatment strategies for chronic kidney disease mineral and bone disorder (CKD-MBD).
Area of Science:
- Nephrology
- Cardiology
- Clinical Trials
Background:
- The optimal dialysate calcium concentration (D-Ca) for chronic hemodialysis (HD) patients remains debated.
- Chronic kidney disease-mineral and bone disorder (CKD-MBD) management involves balancing various parameters.
- Vitamin D receptor activators are used in CKD-MBD treatment, but their interaction with D-Ca needs clarification.
Purpose of the Study:
- To investigate the influence of D-Ca on the efficacy of oral alfacalcidol in HD patients.
- To analyze the effect modification of D-Ca on cardiovascular events and mortality in the J-DAVID trial.
Main Methods:
- A post hoc analysis of the open-label randomized J-DAVID trial involving 976 HD patients.
- Examined CKD-MBD parameters and cardiovascular outcomes over a median of 4 years.
- Utilized multivariable Cox proportional hazard regression with D-Ca as a potential effect modifier and time-varying covariates.
Main Results:
- No significant effect modification by D-Ca was observed for the composite of fatal/non-fatal cardiovascular events.
- D-Ca did not significantly modify the effect of alfacalcidol on all-cause mortality.
- The cardiovascular benefits of alfacalcidol were consistent across different D-Ca levels studied.
Conclusions:
- Dialysate calcium concentration does not appear to significantly modify the cardiovascular benefits of oral alfacalcidol in hemodialysis patients.
- These findings suggest that D-Ca selection may not be a critical factor in alfacalcidol's cardiovascular efficacy.
- Further research may refine CKD-MBD treatment guidelines regarding D-Ca and vitamin D therapy.
Abstract:
The selection of dialysate calcium concentration (D-Ca) is still controversial among chronic hemodialysis (HD) regimens. We examined the trajectories of CKD MBD parameters among the J-DAVID trial participants to see the effect of D-Ca and alfacalcidol. The trial was an open-label randomized clinical trial including 976 HD patients with intact PTH of 180 pg/mL or lower which compared the users of vitamin D receptor activator (oral alfacalcidol) and non-users over a median of 4 years. The main D-Ca used at baseline were 3.0 mEq/L in 70% and 2.5 mEq/L in 25%, respectively. The primary endpoint was the composite of fatal and non-fatal cardiovascular events and the secondary endpoint was all-cause mortality. Multivariable Cox proportional hazard regression analyses in which D-Ca was included as a possible effect modifier and serum laboratory data as time-varying covariates showed no significant effect modification for composite cardiovascular events or all-cause mortality. This post hoc analysis showed that the effects of alfacalcidol on cardiovascular outcomes were not significantly modified by D-Ca.
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