Abstract: FR-PO1072
Effect of Phosphate Binders on Biochemical and Vascular Outcomes in Patients with Non-Dialysis Dependent CKD
Session Information
- Late-Breaking Clinical Trial Posters
November 03, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Mineral Disease
- 1205 Vascular Calcification
Authors
- Kovesdy, Csaba P., University of Tennessee Health Science Center, Memphis, Tennessee, United States
- Lu, Jun Ling, University of Tennessee Health Science Center, Memphis, Tennessee, United States
- Han, Zhongji, University of Tennessee Health Science Center, Memphis, Tennessee, United States
- Thomas, Fridtjof, University of Tennessee Health Science Center, Memphis, Tennessee, United States
- Quarles, Leigh Darryl, University of Tennessee Health Science Center, Memphis, Tennessee, United States
- Jarmukli, Nabil, Salem VAMC, Salem, Virginia, United States
Background
Abnormal phosphate (P) homeostasis develops early in CKD and is associated with adverse clinical outcomes. It is unclear if normalization of P homeostasis results in improved clinical outcomes in patients with non-dialysis dependent (NDD) CKD.
Methods
We randomized 120 patients with CKD stages 3-4 in a 1:1:1 ratio to open-label lanthanum carbonate, calcium acetate or dietary phosphorus restriction for one year (3 months titration and 9 months maintenance). The co-primary outcomes were month 12 (vs. baseline) biochemical (serum and urinary P, PTH, calcium, bone-specific alkaline phosphatase [bALP], and FGF-23) and vascular parameters (coronary artery calcium [Agatson score], arterial stiffness [pulse wave velocity, PWV] and endothelial dysfunction [reactive hyperemia index, RHI]) in all patients. Secondary outcomes were between-treatment differences in change for each parameter between month 12 and baseline. All analyses were intention-to-treat.
Results
Patients were 66.1±11.4 years old, 87% male, 52% African American, 55% diabetic, and their baseline eGFR was 32±10 ml/min/1.73m2. Baseline characteristics were similar between the intervention arms (p>0.5).
107 of 120 (89%) randomized patients completed 12 months of follow-up. Differences were not significant at month 12 (vs. baseline) for any of the outcomes (Table) except bALP and FGF-23. Changes for all outcomes were similar in the three arms except for PTH, which was suppressed more effectively by calcium acetate (p<0.001, data not shown).
Conclusion
A 1-year intervention to limit P absorption using dietary restriction or two different P binders resulted in decreased bALP suggesting improvement in bone turnover, but no other significant changes in biochemical or vascular parameters in patients with NDD CKD.
(NCT01357317)
| Baseline | Month 12 | p | |
| Phosphorus (mg/dl) | 3.8±0.6 | 3.7±0.8 | 0.15 |
| PTH (pg/ml) | 141 (105, 203) | 146 (92,204) | 0.5 |
| TRP (%) | 0.63±0.14 | 0.64±0.16 | 0.5 |
| Calcium (mg/dl) | 9.2±0.5 | 9.1±0.6 | 0.15 |
| Bone-specific ALP (mcg/L) | 15.8 (12.1, 21.1) | 13.8 (10.6, 17.6) | <0.001 |
| FGF-23 (pg/ml) | 133 (86, 189) | 132 (99, 216) | 0.002 |
| PWV (m/sec) | 11.5 (8.7, 13.1) | 10.7 (8.5, 13.7) | 0.4 |
| CAC (Agatson score) | 356 (40,1016) | 309 (51,1048) | 0.5 |
| RHI | 2.03±0.59 | 2.05±0.61 | 0.8 |
P values are for paired t tests
Funding
- Veterans Affairs Support –