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Abstract: TH-PO162

Non-Skeletal Effects of High Doses Versus Minimum Recommended Intake of Vitamin D3 in Renal Transplant Recipients in a Prospective, Multicenter, Double-Blind, Randomized Study

Session Information

Category: Transplantation

  • 1802 Transplantation: Clinical

Authors

  • Courbebaisse, Marie, European Georges Pompidou Hospital, APHP, Paris, France
  • Colas, Sandra, URC/CIC Necker-Cochin, Paris, France
  • Sberro-Soussan, Rebecca, Necker Hospital, APHP, PARIS, France
  • Moal, Valerie, Assistance Publique Hopitaux de Marseille, Marseille, France
  • Le Meur, Yannick, University Hospital, Brest, Brest, France
  • Kamar, Nassim, Toulouse University Hospital, Toulouse, France
  • Albano, Laetitia, Hôpital Pasteur CHU de Nice, Nice, France
  • Thierry, Antoine, CHU La Miletrie, Poitiers, France
  • Dantal, Jacques, Institut de Transplantation Urologie Néphrologie, Nantes, France
  • Allard, Julien, University Hospital Limoges, LImoges, France
  • Moreau, Karine, Pellegrin Hospital, Bordeaux, France
  • Alberti, Corinne, Robert Debré Hospital, Paris, France
  • Thervet, Eric, European Georges Pompidou Hospital, APHP, Paris, France
Background

High doses of vitamin D3 (cholecalciferol, CL) have been advocated to reduce the risk of diabetes mellitus (DM), major cardiovascular events (MACE), and cancer, which are frequent complications in renal transplant recipients (RTR).

Methods

The VITALE study is a prospective, multicenter (30 French transplantation departments), double-blind, controlled trial (NCT01431430). Adult RTR with serum 25(OH)-vitamin D levels (25OHD) <30 ng/mL, were randomized between 12 and 48 months after transplantation to receive either high doses (HD, 100,000 IU) or low doses (LD, 12,000 IU corresponding to the minimum recommended intake, MRI) of CL every 2 weeks for 2 months then monthly for 22 months. The primary objective was to evaluate the effect of HD vs LD on a composite endpoint: DM, MACE, de novo cancer, and patient death. The sample size calculation was based on the assumption of an incidence of a first event of the composite endpoint of 22% in the LD group versus 13% in the HD group. The inclusion of a total of 480 RTR was required to test this hypothesis with a power of 80%.

Results

Between January 2012 and December 2013, 536 RTR (mean (SD) age 50.8 (13.7) years, 335 males) were included. Baseline clinical and biological characteristics did not differ between HD (n=269) and LD (n=267) groups. In the HD and the LD group, 25OHD was 20.2 (8.1) vs 19.2 (7.0) ng/mL at D0 and 43.1 (12.8) vs 25.1 (7.4) ng/mL after 24 months (<0.0001). The intention to treat analysis showed that the number of events of the composite endpoint did not differ between HD and LD groups (15% vs 16%, respectively). There was also no difference for infections (51% vs 47%), acute rejection episodes (3% vs 2%) and graft loss (0.37% in both groups). The number of patients with incident hypercalcemia or hyperphosphatemia did not differ between groups (17% vs 13%, p=0.24, and 5% vs 4%, p=0.41, in HD and LD group respectively). Of note, evolution of valvular calcifications was not significantly different between groups (p= 0.59).

Conclusion

In conclusion, HD of CL are well-tolerated but do not reduce the incidence of non-skeletal complications in RTR when compared to the MRI.

Funding

  • Commercial Support