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 @ 1:07 PM
Ignite Modification Date:
2025-12-24 @ 1:07 PM
NCT ID:
NCT00194961
Eligibility Criteria:
Inclusion Criteria:
* Chronic renal insufficiency as defined by the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS; estimated creatinine clearance \< 75 ml/min/1.73 m2 by the Schwartz formula
* Tanner Stage I or II
* Availability of growth data for the preceding 6 months, and growth failure defined as height \< 5th percentile for chronological age, and/or SDS score for height more negative than -1.88, and/or height velocity SDS \< 0 for six months
Exclusion Criteria:
* Unable or unwilling to adhere to the protocol
* Additional diagnoses that could impair responsiveness to GH, e.g. dwarfism syndromes or significant extra-renal organ disease, e.g. chronic liver disease, diabetes mellitus, AIDS
* Taking medications that influence growth
* Slipped capital femoral epiphysis or avascular necrosis of femoral head
* Constitutional short stature
* Lack of growth potential, e.g. closed epiphysis
* Steroid therapy within previous 3 months
* Known allergy or sensitivity to rhGH
* Previous exposure to a growth hormone product (the patients must be naïve to growth hormone)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT00194961
Study Brief:
Protocol Section:
NCT00194961