Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

The Effect of Sevelamer Carbonate on Critical Variables in the Pathogenesis of Secondary Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191762
• Other study ID #: PhelpsK
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2010
• Last updated: July 30, 2014
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: July 2014
• Source: Phelps, Kenneth R., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• eGFR < 60 ml/min

• age at least 18 years

Exclusion Criteria:

• any primary parathyroid disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• sevelamer carbonate
2400 mg with each meal for 4 weeks
• placebo
3 tablets with each meal

Locations

Country	Name	City	State
United States	Stratton Veterans Affairs Medical Center	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth R. Phelps, M.D.	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate	This outcome measure documented the effect of intestinal phosphate-binding on [PTH]. Fractional change was calculated as ([PTH]post - [PTH]pre)/[PTH]pre, where 'pre' and 'post' referred respectively to baseline [PTH] (before treatment) and [PTH] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.	4 weeks	No
Secondary	Linear Regression of [PTH] on Phosphate Excretion Per Volume of Glomerular Filtrate (EP/Ccr)	EP/Ccr is proportional to the phosphate concentration in the cortical distal nephron ([P]f). The correlation of [PTH] with EP/Ccr tested the hypothesis that [PTH] varies with the phosphate concentration in filtrate of the cortical distal nephron.	at 12 and 16 weeks of trial (pre- and post-treatment)	No