Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT01980004
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 18 years old, being seen at UNC Chapel Hill or Vanderbilt Urology Clinics
2. Documented stone analysis with ≥ 50% calcium phosphate (hydroxyapatite and/or brushite) composition
3. 24 hour urine citrate (≤ 500) on initial evaluation of at least one 24-hour urine study
4. 24 hour urine pH ≥ 6.0 on initial evaluation of at least one 24-hour urine study
Exclusion Criteria:
1. Documented stone analysis with any calcium carbonate or magnesium ammonium phosphate composition
2. Systemic cause for stone disease (primary hyperparathyroidism, complete distal renal tubular acidosis, systemic acidosis, active urinary tract infection)
3. 24 hour urine calcium/kg (\> 4) or 24 hour urine calcium/Cr (\>140) on initial evaluation of at least one 24-hour urine study
4. Concurrent medication therapy (potassium citrate, sodium citrate, sodium bicarbonate, diuretic, angiotensin-converting enzyme inhibitor, angiotensin II receptor antagonist, topiramate, acetazolamide)
5. Renal insufficiency (GFR ≤ 60)
6. Elevated serum potassium level (≥ 4.5) or hyperkalemia
7. Low serum bicarbonate level (\< 24)
8. High serum calcium level (\>10)
9. Pregnancy
10. Inability to obtain informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01980004
Study Brief:
Protocol Section:
NCT01980004