Status:

SUSPENDED

Effect of Cytokines on Growth of Children With Chronic Kidney Failure

Lead Sponsor:

Weill Medical College of Cornell University

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Chronic Renal Insufficiency

Eligibility:

All Genders

6-21 years

Phase:

PHASE4

Brief Summary

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 growt...

Detailed Description

Children with chronic renal failure (CRF; estimated creatinine clearance less than 75ml/min/1.73 m2) and end-stage renal disease (ESRD; dialysis dependent) have marked growth retardation and often do ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 1997

Trial Type :

INTERVENTIONAL

End Date :

May 1 2003

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00194883

Start Date

April 1 1997

End Date

May 1 2003

Last Update

November 21 2017

Active Locations (1)

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Weill Medical College of Cornell University

New York, New York, United States, 10021