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:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT00212758
Eligibility Criteria:
Inclusion Criteria:
* Males and females between 2-18 years of age with chronic renal failure.
* Estimated creatinine clearance between 25-75 ml/min/1.73 m2 calculated by the Schwartz formula.
* Height standard deviation score (SDS) more than -1.88 or annual height velocity SD of more than -2.0 for age and sex for the preceding 6 months.
* No history of growth hormone therapy.
* Cystinosis subjects may qualify for the study if they meet other inclusion criteria and have an estimated creatinine clearance of 25-75 ml/min/1.73 m2.
* Bone age less than 16 years for boys and less than 13 years for girls.
* Subjects with chronic kidney failure who are off steroid therapy or other drugs that interfere with growth for at least 6 months.
Exclusion Criteria:
* Subjects on dialysis and kidney transplant recipients.
* Patients with significant renal osteodystrophy or an intact parathyroid (PTH) level more than 500 pg/ml over the last 3 months prior to enrollment.
* Diabetes mellitus.
* History of malignancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT00212758
Study Brief:
Protocol Section:
NCT00212758