Circadian Rhythm Modulation by Dietary Phosphorus in Chronic Kidney Disease

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the circadian rhythm of serum and salivary phosphorus in patients with chronic kidney disease and determine its' modification in response to changes in dietary phosphate load.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Geoffrey Block

Criteria

Inclusion Criteria:

• Men or women greater than or equal to 18 years of age

• The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board

• Screening estimated glomerular filtration rate (eGRF) greater than or equal to 30 and less than or equal to 45 mL/min/1.72m2 plus or minus 10% for subjects with CKD and greater than 60mL/min for subjects acting as normal healthy controls

• Willing and able to cooperate with all aspects of the study protocol

• No evidence of significant gastrointestinal (GI) disorder that would impair GI motility or function

• No recent active illness or hospitalization within 12 weeks prior to the Day 1/Baseline visit

• No recent or voluntary change in diet within 4 weeks prior to Day 1/ Baseline visit

• No history of intolerance or adverse effects to lanthanum carbonate

• No use of calcium supplements for at least 2 weeks prior to Day 1

• Must have no dietary restrictions or significant allergies and be willing to eat a non-vegan standardized meal

• Subjects taking nutritional vitamin D or any active vitamin D must be on stable doses with no change during the 4 week period prior to Day 1

Exclusion Criteria:

• Current history of drug or alcohol abuse as assessed by the Principal Investigator

• Receiving active chemotherapy treatment for a malignancy

• Has received dialysis or has acute kidney injury within 12 weeks prior to screening or during screening

• Subject has a clinical condition that in the judgement of the Principal Investigator could potentially pose a health risk to the patient while involved int he study

• Received or has received an investigational product (or is currently using an investigational device) within 30 days prior to screening

• Evidence of active (clinically significant) infections within 14 days prior to Day1/ Baseline visit (in the opinion of the investigator)

• Use of phosphate binding medications (calcium carbonate or acetate with meals, lanthanum carbonate, or sevelamer carbonate)within 7 days prior to the Day 1/ Baseline visit

• Significant GI co-morbidity that would preclude use of lanthanum carbonate phosphate binder (e.g. colostomy with unformed stool, uncontrolled diarrhea)