Phase
Condition
Nephropathy
Kidney Failure
Renal Failure
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Non-dialyzed male or female patients with CKD, with a GFR of less than 30mL/min/1.73m²who have elevated serum phosphorus or who develop elevated serum phosphorus followingwashout from phosphorus-binding therapy.
Patients must have written informed consent
Negative serum pregnancy test if appropriate
Expected to be able to comply with protocol procedures and schedule
Exclusion
Exclusion Criteria:
Unstable angina pectoris
Severe congestive heart failure
Severe liver dysfunction
Severe malnutrition
Severe hyperparathyroidism
AIDS (HIV positive subjects without AIDS are not excluded)
Active malignancy for which the subject is receiving chemotherapy or radiation
Subject unlikely to complete the study
History of obstructed bowels or hypersensitivity to any of the study medications ortheir components
History of swallowing disorders such as dysphagia (that would prevent the subject fromtaking the study drug) severe gastrointestinal motility disorders, or major GI tractsurgery
Participation in an investigational drug or device trial within 30 days ofrandomization
Subjects on Vitamin D therapy
Subjects with acute symptoms, in the last month, or current radiographic evidence ofkidney stones
Subjects who have undergone renal transplant or receiving dialysis
Or any condition with makes patient participation not in the patients best interest
Study Design
Study Description
Connect with a study center
University of Texas Health Sciences Center
San Antonio, Texas 78229-3900
United StatesSite Not Available
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