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Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis

NCT00943995 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-05-05

No results posted yet for this 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.

Conditions

  • Kidney Failure, Chronic
  • Renal Dialysis

Interventions

DRUG

somatropin

0.35 mg/Kg/week divided into 3 doses, each dose being given at the end of the dialysis treatment.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • John D Mahan, MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00943995 on ClinicalTrials.gov