A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

National Cooperative Growth Study (NCGS) of Nutropin AQ, Nutropin, and Protropin in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00097617

Enrollment

395

Registered

2004-11-25

Start date

2002-03-31

Completion date

2010-07-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Insufficiency, End-Stage Renal Disease

Brief summary

This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Inclusion criteria

* Children diagnosed with CRI or ESRD and treated with a Genentech GH preparation on or after 1 January 2001 * CRI documented using the Schwartz formula indicates a calculated creatinine clearance (CrCl) of \<=75 mL/min/1.73 m\^2 * Ability to keep follow up appointments throughout the study

Exclusion criteria

* Subjects receiving a non-Genentech GH preparation * Subjects with closed epiphyses * Subjects with active neoplasia * Current participation in another GH clinical study * Current participation in the core study

Outcome results