Phase 3
Completed N=30
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01191762 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate — -11.7; 16.4 percentage of baseline [PTH]
Summary
The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal phosphate binder sevelamer carbonate will be employed to examine whether reductions in phosphate influx alter distal nephron phosphate concentration and the [PTH] required for calcium reabsorption in the expected manner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate |
-11.7; 16.4 | — |
Eligibility Criteria
Inclusion Criteria
- eGFR < 60 ml/min
- age at least 18 years
Exclusion Criteria
- any primary parathyroid disease
Data sourced from ClinicalTrials.gov (NCT01191762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.