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NCT00943995 · ClinicalTrials.gov registry record · Phase 3
Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis
A Phase 3 study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
NCT00943995 is a Phase 3 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 3 participants.
The verdict
NCT00943995, a Phase 3 study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
Study Summary
Hypotheses: 1. The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH) therapy to children receiving in-center hemodialysis (HD) will result in improved growth. 2. The provision of thrice weekly SQ rGH therapy to children receiving in-center HD will result in improved lean body mass, nutritional status and quality of life. TIW rGH treatment regimen (0.35 mg/kg/week divided into 3 doses, each dose being given at the conclusion of the dialysis treatment) for up to 2 years; growth response, Dual energy X-ray absorptiometry (DEXA), and quality of life (QOL) will be measured. The goal is to enroll 20 children who are Tanner 1 with decreased height SDS and/or decreased height velocity standard deviation scoreS (SDS). If this therapy is demonstrated to be efficacious and improves growth and QOL, this therapy could be easily implemented for all eligible children on HD, since parental acceptance should be better without having to administer the rGH at home and compliance for the child will be assured. The investigators thus propose an important study that has the ability to advance their understanding and provide evidence for the best methods to promote growth in children on dialysis. The results of this study will result in important information that will be of value to the entire pediatric nephrologist community, including health care professionals, patients, and families. In a real sense, this study will build on the 2006 Consensus Conference guidelines for evaluation and treatment of growth failure in children with chronic kidney disease (CKD). This will provide evidence for critical management decisions that can help insure better growth opportunities to more children with CKD.
Interventions
- DRUG somatropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943995
The ClinicalTrials.gov registry entry for NCT00943995 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which somatropin is the first listed.
NCT00943995 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00943995 about?
NCT00943995 is a clinical study titled "Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis". Hypotheses: 1. The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH) therapy to children receiving in-center hemodialysis (HD) will result in improved growth. 2. The provision of thrice weekly SQ rGH therapy to children receiving in-center HD will result in improved lean...
What is the current status of trial NCT00943995?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2010-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00943995?
The interventions under investigation include: somatropin (DRUG).
Who is sponsoring clinical trial NCT00943995?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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