Status:
COMPLETED
Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Kidney Failure, Chronic
Renal Dialysis
Eligibility:
All Genders
1-16 years
Phase:
PHASE3
Brief 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 provi...
Detailed Description
Objectives/Aims: 1. To demonstrate the beneficial effects of thrice weekly SQ rGH Rx on growth in children on HD 2. To demonstrate the beneficial effects of thrice weekly SQ rGH Rx in terms of improv...
Eligibility Criteria
Inclusion
- Chronic Renal Failure on Hemodialysis
- Tanner 1
- Bone Age \<12
- Below the 3rd %tile for height or have growth velocity \< 3rd %tile and are not on SQ rGH Rx
- At baseline, study population will also have to have documentation of normal thyroid status, secondary hyperparathyroidism will be controlled in acceptable range (iPTH \< 800), adequate dialysis (Kt/V \>1.2) and normal acid-base status.
- expected to be on hemodialysis at least 6 months
Exclusion
- Anyone not meeting the inclusion criteria.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00943995
Start Date
July 1 2010
End Date
August 1 2012
Last Update
May 5 2015
Active Locations (5)
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1
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
3
Montefiore Medical Center
The Bronx, New York, United States, 10467
4
Children's Memorial Hermann Hospital-TMC
Houston, Texas, United States, 77030