Phase 3
N=30
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
Hyperparathyroidism · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01191762 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate — -11.7; 16.4 percentage of baseline [PTH]
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sevelamer carbonate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kenneth R. Phelps, M.D.
- Primary completion
- Aug 2012
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 | — |
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.
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.