Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
This study is currently recruiting participants.
Verified June 2011 by Phelps, Kenneth R., M.D.
Sponsor:
Phelps, Kenneth R., M.D.
Information provided by:
Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier:
NCT01191762
First received: August 27, 2010
Last updated: June 17, 2011
Last verified: June 2011
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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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191762
Contacts
| Contact: Kenneth R. Phelps, M.D. | 518-626-6415 | kenneth.phelps@va.gov |
| Contact: Deborah Hallenbeck, RN,MSN | 518-626-6419 | deborah.hallenbeck@va.gov |
Locations
| United States, New York | |
| Stratton Veterans Affairs Medical Center | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact: Kenneth R. Phelps, M.D. 518-626-6415 kenneth.phelps@va.gov | |
| Contact: Deborah Hallenbeck, RN,MSN 518-626-6419 kenneth.phelps@va.gov | |
Sponsors and Collaborators
Phelps, Kenneth R., M.D.
Investigators
| Principal Investigator: | Kenneth R. Phelps, M.D. | Stratton VAMC, Albany, NY |
More Information
No publications provided
| Responsible Party: | Kenneth R. Phelps, M.D. |
| ClinicalTrials.gov Identifier: | NCT01191762 History of Changes |
| Other Study ID Numbers: | PhelpsK |
| Study First Received: | August 27, 2010 |
| Last Updated: | June 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Phelps, Kenneth R., M.D.:
|
secondary hyperparathyroidism phosphate calcium chronic kidney disease secondary hyperparathyroidism in patients with stages 3 or 4 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 May 23, 2013