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This trial is conducted in Europe. Objective(s): To evaluate the effect of human growth hormone on infants aged 1 to 2 years with chronic renal insufficiency (CRI) and growth retardation despite an adequate dietary intake.
Trial Design: This is an open, parallel group clinical trial with a duration of one year, in which period 50% of patients will receive GH treatment and the other 50% will act as a control group, without treatment.
Trial Population: The trial will involve a total of 16 infants aged from 12±3 to 24 months suffering chronic renal insufficiency (Glomerular Filtration Rate less than 60 ml/min/1.73 m2), and growth failure and undergoing conservative treatment or peritoneal dialysis. Include the key inclusion and exclusion criteria.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of growth hormone on infants aged 1 to 2 years with CRI and growth retardation growth retardation despite an adequate dietary intake | after 1 year of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives are to assess the safety of rhGH treatment in these infants. Safety assessment will include evaluation of renal function, Bone, IGF-I, IGFBP3 and psychological development |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Coimbra | 3000-075 | Portugal | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20522533 | Derived | Santos F, Moreno ML, Neto A, Ariceta G, Vara J, Alonso A, Bueno A, Afonso AC, Correia AJ, Muley R, Barrios V, Gomez C, Argente J. Improvement in growth after 1 year of growth hormone therapy in well-nourished infants with growth retardation secondary to chronic renal failure: results of a multicenter, controlled, randomized, open clinical trial. Clin J Am Soc Nephrol. 2010 Jul;5(7):1190-7. doi: 10.2215/CJN.07791109. Epub 2010 Jun 3. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Lisbon |
| 1160-045 |
| Portugal |
| Novo Nordisk Investigational Site | Lisbon | 1649-035 | Portugal |
| Novo Nordisk Investigational Site | Porto | 4200-319 | Portugal |
| Novo Nordisk Investigational Site | Badajoz | 06080 | Spain |
| Novo Nordisk Investigational Site | Barakaldo | 48903 | Spain |
| Novo Nordisk Investigational Site | Esplugues Llobregat | 08950 | Spain |
| Novo Nordisk Investigational Site | Lugo | 27004 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28009 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28041 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29011 | Spain |
| Novo Nordisk Investigational Site | Oviedo | 33006 | Spain |
| Novo Nordisk Investigational Site | Pamplona | 31008 | Spain |
| Novo Nordisk Investigational Site | San Sebastián | Spain |
| Novo Nordisk Investigational Site | Santa Cruz de Tenerife | 38010 | Spain |
| Novo Nordisk Investigational Site | Santander | 39008 | Spain |
| Novo Nordisk Investigational Site | Santiago de Compostela | 15705 | Spain |
| Novo Nordisk Investigational Site | Seville | 41013 | Spain |
| Novo Nordisk Investigational Site | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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