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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT00943995 (opens ClinicalTrials.gov in a new tab)Other id907-M02R
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
3 participants (actual)
Sponsor
Nationwide Children's Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2010
Primary completion
Aug 2012
Completion
Aug 2012
First posted
22 Jul 2009 (estimated)
Last update posted
5 May 2015 (estimated)
Conditions
Kidney Failure, Chronic · Renal Dialysis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 3

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

    NCT00943995

    Jul 2010 to Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • somatropinDrug

Arms1

  • Other

    Treatment Arm

    Getting Growth Hormone therapy TIW instead of nightly in the Pediatric Tanner 1 Hemodialysis population.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Primary Endpoints: Changes in Height SDS and Height velocity SDS

    Time frame · Will be monitored every 6 months

Secondary outcomes(1)

  1. Changes in Weight SDS, lean body mass, normalized protein catabolic rate and quality of life.

    Time frame · Will be monitored every 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2007

8 results

Growth hormone treatment during hemodialysis in a randomized trial improves nutrition, quality of life, and cardiovascular risk.

Feldt-Rasmussen et al. 2007Journal of the American Society of Nephrology : JASNcited by 77

PMID 17554147DOI 10.1681/asn.2006111207PUB-17554147

Rights unknown8 results
Source linkSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Month up to 16 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Criteria: * Anyone not meeting the inclusion criteria.

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