Growth Hormone DeficiencyNCGSNCT00616278
National Cooperative Growth Study in CKD
An observational study of Growth Hormone Deficiency, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Growth Hormone Deficiency
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric clinic
Who may be able to join
- Must be a patient of the UC Davis Medical Center pediatric clinic with Chronic Kidney Disease
Who cannot join
- Greater than 18 years old
- Not a patient at the UC Davis Medical Center pediatric clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: National Cooperative Growth Study of Nutropin AQ, Nutropin, Protropin, and Nutropin Depot in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End-Stage Renal Disease (ESRD)
The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects.
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth Failure AND, Chronic Renal Insufficiency OR, End Stage Renal Disease
- Medical subject headings
- Dwarfism, Pituitary, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures of the NCGS are ongoing safety and efficacy of Genentech GH preparations in pediatric growth disorders for which GH is initiated.
Measured: per the study, the pt will be on GH treatement until the physician instructs them to stop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Lavjay Butani, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616278
- Sponsor's protocol ID
- 200412150
- Acronym
- NCGS
- Status last verified
- May 2017
- First submitted
- 4 Feb 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cooperative Growth Study of Nutropin AQ, Nutropin, Protropin, and Nutropin Depot in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End-Stage Renal Disease (ESRD)
- ClinicalTrials.gov ID
- NCT00616278
- Acronym / sponsor ID
- NCGS / 200412150
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth Failure AND, Chronic Renal Insufficiency OR, End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric clinic
Key inclusion criteria (1 listed)
- Must be a patient of the UC Davis Medical Center pediatric clinic with Chronic Kidney Disease
Key exclusion criteria (2 listed)
- Greater than 18 years old
- Not a patient at the UC Davis Medical Center pediatric clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measures of the NCGS are ongoing safety and efficacy of Genentech GH preparations in pediatric growth disorders for which GH is initiated.
Time frame: per the study, the pt will be on GH treatement until the physician instructs them to stop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Related InfoLink provided by the sponsor.
Related trials for Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavjay Butani, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures of the NCGS are ongoing safety and efficacy of Genentech GH preparations in pediatric growth disorders for which GH is initiated. (time frame: per the study, the pt will be on GH treatement until the physician instructs them to stop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.