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Sponsors and Collaborators: |
Denver Nephrologists, P.C. Shire Pharmaceutical Development Fresenius Medical Care North America Genzyme |
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Information provided by: | Denver Nephrologists, P.C. |
ClinicalTrials.gov Identifier: | NCT00785629 |
The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range in patients with chronic kidney disease.
Condition | Intervention |
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Chronic Kidney Disease |
Drug: phosphate binder |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind Randomized Placebo Controlled Trial of Maintenance of Normal Serum Phosphorus in Chronic Kidney Disease (CKD) |
Estimated Enrollment: | 195 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sevelamer carbonate: Active Comparator |
Drug: phosphate binder
starting dose 800mg, titrations to 3200mg QAC
Drug: phosphate binder
starting dose 800mg; titrations to 3200mg QAC
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sevelamer carbonate: Placebo Comparator |
Drug: phosphate binder
starting dose 800mg, titrations to 3200mg QAC
Drug: phosphate binder
starting dose 800mg; titrations to 3200mg QAC
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Calcium acetate: Active Comparator |
Drug: phosphate binder
starting dose 667mg;titrations to 2668mg QAC
Drug: phosphate binder
starting dose 667mg; titrations to 2668mg QAC
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calcium acetate: Placebo Comparator |
Drug: phosphate binder
starting dose 667mg;titrations to 2668mg QAC
Drug: phosphate binder
starting dose 667mg; titrations to 2668mg QAC
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lanthanum carbonate: Active Comparator |
Drug: phosphate binder
starting dose 500mg; titration to 1500mg QAC
Drug: phosphate binder
starting dose 500mg; titrations to 1500mg QAC
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Lanthanum carbonate: Placebo Comparator |
Drug: phosphate binder
starting dose 500mg; titration to 1500mg QAC
Drug: phosphate binder
starting dose 500mg; titrations to 1500mg QAC
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It is the specific aim of this pilot study to assess the feasibility of achieving and maintaining a serum P less than or equal to 3.5 mg/dL (1.13 mmol/L) in patients with eGFR >20 and <45 mL/min with any of the 3 commercially available P lowering agents (calcium acetate, sevelamer carbonate, or lanthanum carbonate). Results of this study will clarify the degree of separation in serum P that can be achieved with the use of P lowering agents and the current standard of care (P binder initiation when P > 5.5 mg/dL or 1.78 mmol/L). Furthermore, this knowledge, combined with analyses of the secondary aims and outcomes of interest, will serve to facilitate the design of a properly powered, randomized, placebo controlled clinical outcomes trial that will firmly establish the necessity of achieving a specific target P in patients with CKD. The secondary aims of this pilot study are to provide insight into the optimal detection of progression of abnormalities in mineral metabolism and their relationship to vascular disease in CKD. The tertiary aim is to evaluate long term outcomes related to phosphorus normalization with respect to renal replacement therapy or death.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: martha s persky, BS, RN, CCRP | 303-364-4775 | mpersky@denverneph.net |
United States, Colorado | |
Denver Nephrologists, PC | Recruiting |
Denver, Colorado, United States, 80230 | |
Contact: martha S Persky, BS, RN, CCRP 303-364-4775 mpersky@denverneph.net |
Principal Investigator: | Geoffrey A Block, MD | Denver Nephrologists, PC |
Responsible Party: | Denver Nephrologists, PC ( Geoffrey A. Block ) |
Study ID Numbers: | PNT001 |
Study First Received: | November 4, 2008 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00785629 History of Changes |
Health Authority: | United States: Food and Drug Administration |
phosphorus secondary hyperparathyroidism vascular calcification |
Sevelamer Renal Insufficiency Hyperparathyroidism, Secondary Urologic Diseases Hyperparathyroidism Renal Insufficiency, Chronic |
Kidney Failure, Chronic Neoplasm Metastasis Kidney Diseases Calcium acetate Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |