Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00234702
First received: October 5, 2005
Last updated: April 29, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Diseases |
Drug: Lanthanum carbonate Drug: Placebo |
Phase 2 |
| 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: | A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Serum phosphorus levels at 8 weeks. [ Time Frame: 8 weeks ]
Secondary Outcome Measures:
- PTH levels, calcium-phosphorus product. [ Time Frame: 8 weeks ]
| Estimated Enrollment: | 84 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Lanthanum carbonate
Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period.
Other Name: FOSRENOL
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Under a physician's care for CKD for > 2 months and are not expected to begin dialysis for 4 months
- Screening estimated GFR of 15-59 mL/1.73 m2
- Serum phosphorus >= 4.7 mg/d following washout
Exclusion Criteria:
- Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum, calcium or magnesium
- Rapidly progressing glomerulonephritis
- Cirrhosis or other clinically significant liver diseases
- Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234702
Locations
| United States, California | |
| VA Greater Los Angeles Health Care System | |
| Los Angeles, California, United States, 90073 | |
| Barnett Research & Communications Medical Corporation | |
| Torrance, California, United States, 90503 | |
| United States, Colorado | |
| Western Nephrology & Metabolic Bone Disease, PC | |
| Thornton, Colorado, United States, 80260 | |
| United States, Florida | |
| Outcomes Research International, Inc. | |
| Hudson, Florida, United States, 34667 | |
| United States, Minnesota | |
| Twin Cities Clinical Research | |
| Brooklyn Center, Minnesota, United States, 55430 | |
| United States, Missouri | |
| St. Louis University/Nephrology | |
| St. Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Oregon | |
| Northwest Renal Clinic | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Nephrology Associates | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Kidney Associates | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | Dr. William F Finn | University of North Carolina, Chapel Hill |
More Information
Additional Information:
Publications:
| Responsible Party: | Timothy Whitaker, M.D., Shire |
| ClinicalTrials.gov Identifier: | NCT00234702 History of Changes |
| Other Study ID Numbers: | SPD405-206 |
| Study First Received: | October 5, 2005 |
| Last Updated: | April 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013