Primary outcomeMean· Day 1 & Day 8
The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)
| Group | Value (mcg/L) | Spread |
|---|---|---|
| Low Dose GH | 115 | 104 |
| Standard Dose GH | 129 | 112 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataA Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
NCTNCT00212758 (opens ClinicalTrials.gov in a new tab)Other idGenentech # 303-MO1
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 17 participants (actual)
- Sponsor
- Oregon Health and Science University · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Jan 2005
- Primary completion
- May 2008
- Completion
- May 2010
- First posted
- 21 Sept 2005 (estimated)
- Last update posted
- 26 Oct 2011 (estimated)
- Conditions
- Kidney Failure, Chronic · Growth Hormone Deficiency
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2005200620072008200920102011
- Ph 4
A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
NCT00212758Jan 2005 to May 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has been shown to be helpful in treating children with chronic kidney disease who fail to grow. The amount of growth that is seen in children treated with growth hormone varies widely for unknown reasons. Growth hormone works by producing another hormone in the liver called insulin-like growth factor-1, or IGF-1 for short. IGF-1 stimulates the bones to grow. The amount of IGF-1 in the blood may directly affect the amount of growth in each child. At this time, growth hormone therapy in children depends on giving a certain dose of growth hormone for each child based on his or her weight. If after 3-6 months on this dose of growth hormone the change in height is not enough, then the dose of growth hormone is increased until enough growth is seen. This method of dosing of growth hormone may take a long time and is complicated and time-consuming. The purpose of this study is to measure the amount of IGF-1 produced by the body as a result of giving 2 different doses of growth hormone in children for 7 days only. The study investigator hopes to find the most favorable level of IGF-1 generated after 7 days of growth hormone that correlates with good growth of children with kidney disease. Then instead of dosing growth hormone by weight, like is done now, researchers can dose growth hormone by the amount of IGF-1 that the body produces. Being able to dose more effectively will save valuable time for the child to grow and will shorten the overall duration of growth hormone therapy. The investigators will also determine the effect of inflammatory cytokines Il-6 and TNF-alpha on growth hormone insensitivity and hence IGF-1 generation test in the same population.
Interventions
- Nutropin AQDrug
Arms2
Active comparator
Low- Standard GH dose
This arm will receive Low dose of growth hormone (GH) (Nutropin AQ), for 7 days in a cross over design. Low dose GH will be 0.025 mg/kg/day. This will be followed by 2 weeks of wash out, then subjects will receive and the standard dose of Nutropin AQ (GH) at 0.05 mg/kg/dose given subcutaneously for another 7 days. IGF-I levels are measured after 7 days of the Low and the Standard dose of GH. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months and re-evaluated. If growth is adequate then subjects will continue on standard dose of GH for another 6 months for a total of 12 months.
Active comparator
Standard-Low GH dose (7 Days)
This arm will receive Standard dose of growth hormone (GH) (Nutropin AQ), for 7 days in a cross over design. Standard dose GH will be 0.5 mg/kg/day. This will be followed by 2 weeks of wash out, then subjects will receive and the Low dose of Nutropin AQ (GH) at 0.025 mg/kg/dose given subcutaneously for another 7 days. IGF-I levels are measured after 7 days of the Low and the Standard dose of GH. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months and re-evaluated. If growth is adequate then subjects will continue on standard dose of GH for another 6 months for a total of 12 months.
Primary outcomes1
Outcomes the sponsor listed as primary.
The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)
Time frame · Day 1 & Day 8
Registry description
We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).
Secondary outcomes(1)
Change in Height at 56 Weeks
Time frame · week 1, week 56
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· week 1, week 56
Change in Height at 56 Weeks
| Group | Value (cm) | Spread |
|---|---|---|
| All Participants | 10.3 | 1.1 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| All ParticipantsThere will be 2 arms in the study who will be randomized in a cross over design. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months. | – | 0 / 17 | 0 / 17 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedAl-Uzri A, Swinford RD, Nguyen T, Jenkins R, Gunsul A, Kachan-Liu SS, Rosenfeld R. The utility of the IGF-I generation test in children with chronic kidney disease. Pediatr Nephrol. 2013 Dec;28(12):2323-33. doi: 10.1007/s00467-013-2570-0. Epub 2013 Sep 7. PMID 24013497
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 2 Years up to 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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