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Circadian Rhythm Modulation by Dietary Phosphorus in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geoffrey Block, Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier:
NCT01341678
First received: April 23, 2011
Last updated: February 10, 2014
Last verified: April 2011
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Drug: Lanthanum Carbonate
Dietary Supplement: NeutraPhos
Other: Diet Only

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Circadian Rhythm Modulation by Dietary Phosphorus in Chronic Kidney Disease (CKD)

Resource links provided by NLM:


Further study details as provided by Denver Nephrologists, P.C.:

Primary Outcome Measures:
  • Circadian rhythm of serum phosphorus [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    After 1 week of a controlled phosphorus diet patients will be hospitalized for 24 hours and serum phosphorus will be obtained every 4 hours. After a 4 day washout, each subject will cross over to a low phosphorus diet (for 1 week) followed by a 4 day washout and cross over to a high phosphorus diet for 1 week. At the end of each weekly diet a 24 hour hospitalization will occur with samples collected every 4 hours.

  • Circadian rhythm of plasma fibroblast growth factor 23 (FGF23) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    After 1 week of a controlled phosphorus diet patients will be hospitalized for 24 hours and FGF23 will be obtained every 4 hours. After a 4 day washout, each subject will cross over to a low phosphorus diet (for 1 week) followed by a 4 day washout and cross over to a high phosphorus diet for 1 week. At the end of each weekly diet a 24 hour hospitalization will occur with samples collected every 4 hours.

  • Circadian rhythm of salivary phosphorus [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    After 1 week of a controlled phosphorus diet patients will be hospitalized for 24 hours and salivary phosphorus will be obtained every 4 hours. After a 4 day washout, each subject will cross over to a low phosphorus diet (for 1 week) followed by a 4 day washout and cross over to a high phosphorus diet for 1 week. At the end of each weekly diet a 24 hour hospitalization will occur with samples collected every 4 hours.


Enrollment: 15
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Normal Phosphorus Diet
Diet containing 1500mg of phosphorus per day
Other: Diet Only
Diet containing 1500mg of phosphorus
Restricted Phosphorus Diet
Diet containing 750mg of phosphorus per day and administration of a phosphate binder (lanthanum carbonate)
Drug: Lanthanum Carbonate
Diet will be supplemented with 1000mg at each meal
Other Name: Fosrenol
High Phosphorus Diet
Diet containing 3000mg of phosphorus per day and phosphorus supplementation (NeutraPhos)
Dietary Supplement: NeutraPhos
Diet will be supplemented with NeutraPhos
Other Name: Phosphorus supplementation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341678

Locations
United States, Colorado
Denver Nephrologists, PC
Denver, Colorado, United States, 80230
Sponsors and Collaborators
Geoffrey Block
Investigators
Principal Investigator: Geoffrey A Block, MD Denver Nephrologists, PC
  More Information

No publications provided

Responsible Party: Geoffrey Block, Director of Research, Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier: NCT01341678     History of Changes
Other Study ID Numbers: CMD 004
Study First Received: April 23, 2011
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Nephrologists, P.C.:
chronic kidney disease
phosphorus
circadian rhythm
saliva

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014