Status:
COMPLETED
Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Genzyme, a Sanofi Company
Purdue University
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
The purpose of this study is to gain a better understanding of calcium absorption and metabolism in patients with Chronic Kidney Disease (CKD) using calcium balance and kinetic methods.
Detailed Description
The purpose of this study is to gain a better understanding of calcium absorption and metabolism in patients with Chronic Kidney Disease (CKD). It is important that the body get enough calcium to supp...
Eligibility Criteria
Inclusion
- Patients with a GFR of \< 45 ml/min;
- Intact serum PTH \> 37 pg/ml;
- Age \> 35 years (both genders and all races);
- Able to perform two three-week balance studies;
- Not on oral calcium or vitamin D other than multi vitamin, or willing to stop calcium or vitamin D for one month prior to entry in the study (day 1 of first calcium balance period);
- Female patients must be post-menopausal (defined as last menstrual period at least 12 months prior to screening visit) or surgically sterile by hysterectomy;
- On stable doses of diuretics, bisphosphonates, anti-epileptics (except dilantin) for at least 2 months.
Exclusion
- Serious underlying systemic disease (including uncontrolled diabetes, lupus, hypertension, amyloid, etc);
- Taking drugs that alter calcium and phosphate balance or homeostasis including high dose cholecalciferol or ergocalciferol (1000 U/day or 50,000U/ wk, respectively), active vitamin D metabolites, calcimimetics, PTH analogues in the last 30 days;
- Taking drugs that the investigator feels will alter calcium balance;
- Plan to initiate dialysis in the next six months;
- Hypercalcemia defined as serum calcium \> 10.5 mg/dl;
- Hyperphosphatemia defined as serum phosphate \>5.5mg/ml;
- Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, bariatric surgery;
- Smoking
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01161407
Start Date
June 1 2010
End Date
November 1 2011
Last Update
July 29 2014
Active Locations (1)
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1
Indiana University Hospital - Clinical Research Center
Indianapolis, Indiana, United States, 46202