Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
Completed · Not applicable · Has a placebo group
Conditions studied: Chronic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT01161407
- Run by
- Indiana University
- People needed
- 12
- Starts
- 2010-06-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2014-07-29
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Indiana University Hospital - Clinical Research Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.