A Phase 3 interventional study of potassium citrate and potassium phosphate in Hypercalciuria and Kidney Calculi, sponsored by National Center for Research Resources (NCRR). Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by National Center for Research Resources (NCRR) · Phase 3, Interventional, and Treatment
OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria.
II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
Patients receive potassium phosphate or potassium citrate tablets twice a day for 3 years.
33 studies on the registry are indexed under Hypercalciuria; 4 are open to participants now.
This study's enrollment of 300 is above the median of 40 across 25 interventional studies indexed under Hypercalciuria.
Browse Hypercalciuria studies →National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No study locations are listed for this record.
This study is completed, as verified in Jun 2000. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Potassium Citrate · Potassium phosphate
National Center for Research Resources (NCRR) →