Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01191762
• Date of registration: 27/08/2010
• Primary sponsor: Phelps, Kenneth R., M.D.
• Public title: Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
• Scientific title: The Effect of Sevelamer Carbonate on Critical Variables in the Pathogenesis of Secondary Hyperparathyroidism
• Date of first enrolment: April 2010
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01191762
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Kenneth R. Phelps, M.D.

• Name: Kenneth R. Phelps, M.D.

• Name: Kenneth R. Phelps, M.D.
• Affiliation: Stratton VAMC, Albany, NY

Key inclusion & exclusion criteria

Inclusion Criteria:

- eGFR < 60 ml/min

- age at least 18 years

Exclusion Criteria:

- any primary parathyroid disease



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Hyperparathyroidism

Intervention(s)

Drug: placebo

Drug: sevelamer carbonate

Primary Outcome(s)

Fractional reduction in [PTH] in CKD after a 4-week course of sevelamer carbonate [Time Frame: 16 weeks]

Secondary Outcome(s)

Correlation of [PTH] to phosphate excretion per volume of glomerular filtrate [Time Frame: 16 weeks]

Secondary ID(s)

PhelpsK

Source(s) of Monetary Support

Please refer to primary and secondary sponsors