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Trial · Interventional

SuspendedPhase 4Registry data

Effect of Cytokines on Growth of Children With Chronic Kidney Failure

NCTNCT00194883 (opens ClinicalTrials.gov in a new tab)Other id0596-363
Open at ClinicalTrials.govAsk about this trial

This trial is suspended.

The registry gives no reason.

Overview

Status
Suspended
Phase
Phase 4
Enrollment
50 participants
Sponsor
Weill Medical College of Cornell University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 1997
Primary completion
Not stated
Completion
May 2003
First posted
19 Sept 2005 (estimated)
Last update posted
21 Nov 2017
Conditions
Chronic Renal Insufficiency

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1998200020022004
  1. Ph 4

    Effect of Cytokines on Growth of Children With Chronic Kidney Failure

    NCT00194883

    Apr 1997 to May 2003

    Suspended

Registry summary

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

Children with chronic kidney failure often do not grow well. This study examines the possible causes of growth failure in these children and the response to recombinant human growth hormone. The growth hormone-insulin-like growth factor axis will be studied in relation to biochemical and immunological parameters as well as body compositional changes pre- and post recombinant human growth hormone therapy.

Interventions

  • Recombinant Human Growth HormoneDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To examine the efficacy of recombinant human growth hormone in improving growth velocity in prepubertal children with growth failure secondary to chronic kidney disease.

Secondary outcomes(1)

  1. To examine how recombinant human growth hormone effects body composition, the GH-IGF axis proteins and biochemical/immunological parameters in children with growth failure secondary to chronic kidney disease

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.

A trial that is still running, or that stopped early, may post results later.

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.

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Months up to 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Current height \< 2SD (or \< 3rd percentile) for chronological age * Chronic renal failure (estimated creatinine clearance \<75 mL/min/1.73m2) or ESRD (as defined by receiving maintenance HD or PD) * Age \< 21 years and /or growth potential demonstrable by bone age Exclusion Criteria: * Unable or unwilling to adhere to the protocol * Additional diagnoses that could impair responsiveness to GH, e.g. dwarfism syndromes, significant extra-renal organ disease, e.g. chronic liver disease, or chronic corticosteroid therapy

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