Completed

Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

potassium citrate

+ potassium phosphate

Drug
Who is being recruted

Calculi+16

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 1995
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00004284
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CalculiFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary CalculiUrologic DiseasesPathological Conditions, AnatomicalUrological ManifestationsDisease AttributesFemale Urogenital DiseasesMale Urogenital DiseasesUrolithiasisUrogenital DiseasesKidney CalculiRare DiseasesNephrolithiasisHypercalciuria

Criteria

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-- Creatinine clearance 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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers