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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
Shire Pharmaceutical Development |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00438932 |
Purpose
The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease |
Drug: Lanthanum Carbonate Dietary Supplement: Low Phosphorus Diet |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment, Efficacy Study |
| Official Title: | Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A, B, C, or D: Placebo Comparator
25% of subjects will receive binders plus a phosphate restricted diet(A); 25% binders + unrestricted phosphate diet (B); 25% placebo + phosphate restricted diet (C); 25% placebo + unrestricted phosphate diet (D)
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Drug: Lanthanum Carbonate
A and B will receive lanthanum carbonate 1000mg 3x/day; A will be on a low phosphorus diet and B will be on an unrestricted phosphorus diet. C and D will be on placebo, C will be a low phosphorus diet and D will be an unrestricted phosphorus diet
Dietary Supplement: Low Phosphorus Diet
Groups A and C will be on a low phosphorus diet which will consist of 800 mg of phosphorus per day and the Group B and D will be on an unrestricted diet will contain 1550 mg of phosphorus per day (800 mg of which is dietary and 750mg of Neutraphos (3 packets/day; each packet is 250mg.
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Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karen Laliberte, RN | 617-724-1413 | KLALIBERTE@PARTNERS.ORG |
| Contact: Tamara Isakova, MD | 617-726-5050 | tisakova@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Karen Laliberte, MD 617-724-1413 KLALIBERTE@PARTNERS.ORG | |
| Contact: Tamara Isakova, MD 617-726-5050 tisakova@partners.org | |
| Sub-Investigator: Tamara Isakova, MD | |
| Sub-Investigator: Orlando M Gutierrez, MD | |
| Principal Investigator: | Myles Wolf, MD, MMSc | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( Harald Jueppner, M.D. ) |
| Study ID Numbers: | 2005P000486 |
| Study First Received: | February 20, 2007 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00438932 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
phosphate, phosphorus, FGF-23, PTH, 1,25D |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |