Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier:
NCT01191762
First received: August 27, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hyperparathyroidism
Chronic Kidney Disease
Drug: sevelamer carbonate
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Phelps, Kenneth R., M.D.:

Primary Outcome Measures:
  • Fractional reduction in [PTH] in CKD after a 4-week course of sevelamer carbonate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of [PTH] to phosphate excretion per volume of glomerular filtrate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevelamer carbonate
2400 mg (3 pills) with each meal
Drug: sevelamer carbonate
2400 mg with each meal for 4 weeks
Other Name: sevelamer carbonate = Renvela (Genzyme)
Placebo Comparator: placebo control
3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.
Drug: placebo
3 tablets with each meal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • eGFR < 60 ml/min
  • age at least 18 years

Exclusion Criteria:

  • any primary parathyroid disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191762

Locations
United States, New York
Stratton Veterans Affairs Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Kenneth R. Phelps, M.D.
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Kenneth R. Phelps, M.D. Stratton VAMC, Albany, NY
  More Information

No publications provided

Responsible Party: Kenneth R. Phelps, M.D., Principal Investigator, Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier: NCT01191762     History of Changes
Other Study ID Numbers: PhelpsK
Study First Received: August 27, 2010
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Phelps, Kenneth R., M.D.:
secondary hyperparathyroidism
phosphate
calcium
chronic kidney disease

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014