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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00212758 |
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Date of registration:
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14/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
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Scientific title:
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IGF-1 Generation Test in Children With Chronic Kidney Disease |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00212758 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Amira Y Al-Uzri, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
2 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Kidney Failure, Chronic
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Intervention(s)
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Drug: Nutropin AQ
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Primary Outcome(s)
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The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)
[Time Frame: Day 1 & Day 8]
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Secondary Outcome(s)
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Change in Height at 56 Weeks
[Time Frame: week 1, week 56]
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Secondary ID(s)
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Genentech # 303-MO1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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