Kidney Failure, ChronicPhase 3NCT00943995
Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis
A Phase 3 study testing somatropin in people with Kidney Failure, Chronic and Renal Dialysis, run by Nationwide Children's Hospital at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Kidney Failure, Chronic, Renal Dialysis
- What is being tested?
- somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2010to Aug 2012
- Phase
- Phase 3
- 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 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Anyone not meeting the inclusion criteria.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Children's Memorial Hermann Hospital-TMC
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: TIW Growth Hormone Therapy in Children on Hemodialysis
Hypotheses:
- The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH) therapy to children receiving in-center hemodialysis (HD) will result in improved growth.
- 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.
Read more
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.
Read the detailed description
Objectives/Aims:
- To demonstrate the beneficial effects of thrice weekly SQ rGH Rx on growth in children on HD
- To demonstrate the beneficial effects of thrice weekly SQ rGH Rx in terms of improved lean body mass, nutritional status and quality of life in children on HD
Study Design:
- Study group - Provision of standard weekly dose of SQ rGH (0.35 mg/kg/week divided into 3 doses, each dose being given at the conclusion of dialysis therapy) for up to 2 years to growth retarded (Height SDS < -1.88 or Height velocity < -1.88 SD) children receiving HD who are naïve to rGH or who have not been on rGH for at least 12 months. Inclusion criteria are: medically cleared for SQ rGH Rx (14); growth potential based on Tanner stage 1 with open epiphyses on Bone Age radiographs (Bone age < 12 years); expected to require HD for at least 6 more months; at least 6 months of standardized historical pre-study anthropometric data (including stadiometer height). Exclusion criteria include all medical factors that indicate that rGH therapy should not be used (14), e.g., poor nutritional status, poorly controlled acidosis, poor dialysis adequacy (defined by Kt/V < 1.2), poorly controlled renal osteodystrophy (PTH > 800). Once the complicating factor is addressed and corrected, the child may be considered for the study.
- SQ rGH to be provided in-center at the conclusion of dialysis session three times weekly for up to 24 months. SQ rGH dose to be adjusted based on dry (euvolemic) weight every month during the intervention.
- Baseline and monitoring data obtained on each patient on SQ rGH Rx. This will include stadiometer measured height for at least 6 months prior to initiation of SQ rGH Rx to provide important baseline height and growth velocity to be used to determine magnitude of the response.
- For children with suboptimal response after 6 months of standard SQ rGH Rx dose (annualized growth rate < 2 cm more than the preceding year), the rGH dose will be increased to 0.70 mg/kg/week divided into 3 doses (similar to the reported "pubertal" dosing regimen used in some GH deficient children).
Baseline data: Height (stadiometer), Weight, BMI, Height SDS, Height velocity SDS (historical past 6 months), Weight SDS, BMI SDS, Hb, BUN, nPCR, serum albumin, serum calcium, serum phosphorus, iPTH, electrolytes, high sensitivity CRP (as a marker of inflammation), dialysis adequacy (defined by single and double pool Kt/V - Kt/V is a unitless number used to quantify hemodialysis and peritoneal dialysis treatment adequacy: K - dialyzer clearance of urea, t - dialysis time, V - patient's total body water; in HD the target is 1.2), IGF-1, IGFBP-3, hip films and bone age (4,5,6,9). In addition, lean body mass/and fat mass will be assessed by DEXA (to standardize the determination of LBM, DEXA to be done mid week, after the dialysis treatment, to avoid the excess fluid commonly present after 2 days off dialysis each weekend) and quality of life will be assessed by the PedsQL 4.0 Generic Core Scales (10). The nutritional parameters that will be determined (wt/ht, ht SDS, BMI, nPCR and serum albumin) represent the currently used assessments of nutrition for these patients and have been validated as best measures of nutrition in children on dialysis (12).
Assessments to be repeated at the following intervals:
- Height (stadiometer), Weight, Hgb, BUN, nPCR, serum albumin, serum calcium, phosphorus, and electrolytes, Kt/V - monthly
- CRP, iPTH, IGF-1, IGFBP-3 - every 3 months
- PedsQL - every 6 months
- DEXA and Bone Age - yearly (and within 1 week of renal transplant if this occurs anytime 6 months after start of study) - DEXA and Bone Age results will be sent to Nationwide Children's and analyzed by our collaborating pediatric radiologist (Larry Binkovitz, MD).
- Conditions
- Kidney Failure, Chronic, Renal Dialysis
- Being tested
- somatropin
- Keywords
- End Stage Kidney Disease, Kidney Failure, Short stature, Growth Hormone therapy
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Also called Nutropin AQ
0.35 mg/Kg/week divided into 3 doses, each dose being given at the end of the dialysis treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Getting Growth Hormone therapy TIW instead of nightly in the Pediatric Tanner 1 Hemodialysis population. Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints: Changes in Height SDS and Height velocity SDS
Measured: Will be monitored every 6 months
Secondary outcomes (1)
Changes in Weight SDS, lean body mass, normalized protein catabolic rate and quality of life.
Measured: Will be monitored every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJul 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, John Mahan, Nationwide Children's Hospital
- Investigators
- John D Mahan, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943995
- Sponsor's protocol ID
- 907-M02R
- Status last verified
- May 2015
- First submitted
- 21 Jul 2009
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feldt-Rasmussen B, Lange M, Sulowicz W, Gafter U, Lai KN, Wiedemann J, Christiansen JS, El Nahas M; APCD Study Group. Growth hormone treatment during hemodialysis in a randomized trial improves nutrition, quality of life, and cardiovascular risk. J Am Soc Nephrol. 2007 Jul;18(7):2161-71. doi: 10.1681/ASN.2006111207. Epub 2007 Jun 6.
PubMed 17554147Goldstein SL, Currier H, Watters L, Hempe JM, Sheth RD, Silverstein D. Acute and chronic inflammation in pediatric patients receiving hemodialysis. J Pediatr. 2003 Nov;143(5):653-7. doi: 10.1067/S0022-3476(03)00534-1.
PubMed 14615740Goldstein SL. Adequacy of dialysis in children: does small solute clearance really matter? Pediatr Nephrol. 2004 Jan;19(1):1-5. doi: 10.1007/s00467-003-1368-x. Epub 2003 Nov 22.
PubMed 14673636Goldstein SL, Brem A, Warady BA, Fivush B, Frankenfield D. Comparison of single-pool and equilibrated Kt/V values for pediatric hemodialysis prescription management: analysis from the Centers for Medicare & Medicaid Services Clinical Performance Measures Project. Pediatr Nephrol. 2006 Aug;21(8):1161-6. doi: 10.1007/s00467-006-0112-8. Epub 2006 May 17.
PubMed 16705459Gorman G, Frankenfield D, Fivush B, Neu A. Linear growth in pediatric hemodialysis patients. Pediatr Nephrol. 2008 Jan;23(1):123-7. doi: 10.1007/s00467-007-0631-y. Epub 2007 Oct 16.
PubMed 17934888Juarez-Congelosi M, Orellana P, Goldstein SL. Normalized protein catabolic rate versus serum albumin as a nutrition status marker in pediatric patients receiving hemodialysis. J Ren Nutr. 2007 Jul;17(4):269-74. doi: 10.1053/j.jrn.2007.04.002.
PubMed 17586426Kari JA, Rees L. Growth hormone for children with chronic renal failure and on dialysis. Pediatr Nephrol. 2005 May;20(5):618-21. doi: 10.1007/s00467-004-1801-9. Epub 2005 Mar 22.
PubMed 15782308Mahan JD, Warady BA; Consensus Committee. Assessment and treatment of short stature in pediatric patients with chronic kidney disease: a consensus statement. Pediatr Nephrol. 2006 Jul;21(7):917-30. doi: 10.1007/s00467-006-0020-y. Epub 2006 May 30.
PubMed 16773402Neu AM, Bedinger M, Fivush BA, Warady BA, Watkins SL, Friedman AL, Brem AS, Goldstein SL, Frankenfield DL. Growth in adolescent hemodialysis patients: data from the Centers for Medicare & Medicaid Services ESRD Clinical Performance Measures Project. Pediatr Nephrol. 2005 Aug;20(8):1156-60. doi: 10.1007/s00467-005-1889-6. Epub 2005 Jun 24.
PubMed 15977027
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIW Growth Hormone Therapy in Children on Hemodialysis
- ClinicalTrials.gov ID
- NCT00943995
- Acronym / sponsor ID
- 907-M02R
- Conditions
- Kidney Failure, Chronic, Renal Dialysis
- Keywords
- End Stage Kidney Disease, Kidney Failure, Short stature, Growth Hormone therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Jul 2009 (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.
Hypotheses:
- The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH) therapy to children receiving in-center hemodialysis (HD) will result in improved growth.
- 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.
Detailed description
Objectives/Aims:
- To demonstrate the beneficial effects of thrice weekly SQ rGH Rx on growth in children on HD
- To demonstrate the beneficial effects of thrice weekly SQ rGH Rx in terms of improved lean body mass, nutritional status and quality of life in children on HD
Study Design:
- Study group - Provision of standard weekly dose of SQ rGH (0.35 mg/kg/week divided into 3 doses, each dose being given at the conclusion of dialysis therapy) for up to 2 years to growth retarded (Height SDS < -1.88 or Height velocity < -1.88 SD) children receiving HD who are naïve to rGH or who have not been on rGH for at least 12 months. Inclusion criteria are: medically cleared for SQ rGH Rx (14); growth potential based on Tanner stage 1 with open epiphyses on Bone Age radiographs (Bone age < 12 years); expected to require HD for at least 6 more months; at least 6 months of standardized historical pre-study anthropometric data (including stadiometer height). Exclusion criteria include all medical factors that indicate that rGH therapy should not be used (14), e.g., poor nutritional status, poorly controlled acidosis, poor dialysis adequacy (defined by Kt/V < 1.2), poorly controlled renal osteodystrophy (PTH > 800). Once the complicating factor is addressed and corrected, the child may be considered for the study.
- SQ rGH to be provided in-center at the conclusion of dialysis session three times weekly for up to 24 months. SQ rGH dose to be adjusted based on dry (euvolemic) weight every month during the intervention.
- Baseline and monitoring data obtained on each patient on SQ rGH Rx. This will include stadiometer measured height for at least 6 months prior to initiation of SQ rGH Rx to provide important baseline height and growth velocity to be used to determine magnitude of the response.
- For children with suboptimal response after 6 months of standard SQ rGH Rx dose (annualized growth rate < 2 cm more than the preceding year), the rGH dose will be increased to 0.70 mg/kg/week divided into 3 doses (similar to the reported "pubertal" dosing regimen used in some GH deficient children).
Baseline data: Height (stadiometer), Weight, BMI, Height SDS, Height velocity SDS (historical past 6 months), Weight SDS, BMI SDS, Hb, BUN, nPCR, serum albumin, serum calcium, serum phosphorus, iPTH, electrolytes, high sensitivity CRP (as a marker of inflammation), dialysis adequacy (defined by single and double pool Kt/V - Kt/V is a unitless number used to quantify hemodialysis and peritoneal dialysis treatment adequacy: K - dialyzer clearance of urea, t - dialysis time, V - patient's total body water; in HD the target is 1.2), IGF-1, IGFBP-3, hip films and bone age (4,5,6,9). In addition, lean body mass/and fat mass will be assessed by DEXA (to standardize the determination of LBM, DEXA to be done mid week, after the dialysis treatment, to avoid the excess fluid commonly present after 2 days off dialysis each weekend) and quality of life will be assessed by the PedsQL 4.0 Generic Core Scales (10). The nutritional parameters that will be determined (wt/ht, ht SDS, BMI, nPCR and serum albumin) represent the currently used assessments of nutrition for these patients and have been validated as best measures of nutrition in children on dialysis (12).
Assessments to be repeated at the following intervals:
- Height (stadiometer), Weight, Hgb, BUN, nPCR, serum albumin, serum calcium, phosphorus, and electrolytes, Kt/V - monthly
- CRP, iPTH, IGF-1, IGFBP-3 - every 3 months
- PedsQL - every 6 months
- DEXA and Bone Age - yearly (and within 1 week of renal transplant if this occurs anytime 6 months after start of study) - DEXA and Bone Age results will be sent to Nationwide Children's and analyzed by our collaborating pediatric radiologist (Larry Binkovitz, MD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Drug: somatropinGetting Growth Hormone therapy TIW instead of nightly in the Pediatric Tanner 1 Hemodialysis population. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Anyone not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropinAlso: Nutropin AQ0.35 mg/Kg/week divided into 3 doses, each dose being given at the end of the dialysis treatment. | Drug | Treatment Arm |
Primary outcome
Primary Endpoints: Changes in Height SDS and Height velocity SDS
Time frame: Will be monitored every 6 months
1 secondary outcome
Changes in Weight SDS, lean body mass, normalized protein catabolic rate and quality of life.
Time frame: Will be monitored every 6 months
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 5 May 2015.
- Background: PubMed 17554147Feldt-Rasmussen B, Lange M, Sulowicz W, Gafter U, Lai KN, Wiedemann J, Christiansen JS, El Nahas M; APCD Study Group. Growth hormone treatment during hemodialysis in a randomized trial improves nutrition, quality of life, and cardiovascular risk. J Am Soc Nephrol. 2007 Jul;18(7):2161-71. doi: 10.1681/ASN.2006111207. Epub 2007 Jun 6.
- Background: PubMed 14615740Goldstein SL, Currier H, Watters L, Hempe JM, Sheth RD, Silverstein D. Acute and chronic inflammation in pediatric patients receiving hemodialysis. J Pediatr. 2003 Nov;143(5):653-7. doi: 10.1067/S0022-3476(03)00534-1.
- Background: PubMed 14673636Goldstein SL. Adequacy of dialysis in children: does small solute clearance really matter? Pediatr Nephrol. 2004 Jan;19(1):1-5. doi: 10.1007/s00467-003-1368-x. Epub 2003 Nov 22.
- Background: PubMed 16705459Goldstein SL, Brem A, Warady BA, Fivush B, Frankenfield D. Comparison of single-pool and equilibrated Kt/V values for pediatric hemodialysis prescription management: analysis from the Centers for Medicare & Medicaid Services Clinical Performance Measures Project. Pediatr Nephrol. 2006 Aug;21(8):1161-6. doi: 10.1007/s00467-006-0112-8. Epub 2006 May 17.
- Background: PubMed 17934888Gorman G, Frankenfield D, Fivush B, Neu A. Linear growth in pediatric hemodialysis patients. Pediatr Nephrol. 2008 Jan;23(1):123-7. doi: 10.1007/s00467-007-0631-y. Epub 2007 Oct 16.
- Background: PubMed 17586426Juarez-Congelosi M, Orellana P, Goldstein SL. Normalized protein catabolic rate versus serum albumin as a nutrition status marker in pediatric patients receiving hemodialysis. J Ren Nutr. 2007 Jul;17(4):269-74. doi: 10.1053/j.jrn.2007.04.002.
- Background: PubMed 15782308Kari JA, Rees L. Growth hormone for children with chronic renal failure and on dialysis. Pediatr Nephrol. 2005 May;20(5):618-21. doi: 10.1007/s00467-004-1801-9. Epub 2005 Mar 22.
- Background: PubMed 16773402Mahan JD, Warady BA; Consensus Committee. Assessment and treatment of short stature in pediatric patients with chronic kidney disease: a consensus statement. Pediatr Nephrol. 2006 Jul;21(7):917-30. doi: 10.1007/s00467-006-0020-y. Epub 2006 May 30.
- Background: PubMed 15977027Neu AM, Bedinger M, Fivush BA, Warady BA, Watkins SL, Friedman AL, Brem AS, Goldstein SL, Frankenfield DL. Growth in adolescent hemodialysis patients: data from the Centers for Medicare & Medicaid Services ESRD Clinical Performance Measures Project. Pediatr Nephrol. 2005 Aug;20(8):1156-60. doi: 10.1007/s00467-005-1889-6. Epub 2005 Jun 24.
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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.
John D Mahan, MD principal investigator
Nationwide Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing somatropin in people with Kidney Failure, Chronic and Renal Dialysis, run by Nationwide Children's Hospital at 5 sites 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 6 inclusion and 1 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 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary Endpoints: Changes in Height SDS and Height velocity SDS (time frame: Will be monitored every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943995, which also lists 9 linked publications.
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 5 May 2015.