Clinical Trial Details
| Trial ID: | L0211 |
| Source ID: | NCT00184769 |
| Associated Drug: | Somatropin |
| Title: | Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Chronic Renal Insufficiency |
| Interventions: | DRUG: somatropin |
| Outcome Measures: | Primary: 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 | Secondary: 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 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE4 |
| Enrollment: | 16 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 1998-01-29 |
| Completion Date: | 2005-12-21 |
| Results First Posted: | |
| Last Update Posted: | 2017-02-27 |
| Locations: | Novo Nordisk Investigational Site, Coimbra, 3000-075, Portugal|Novo Nordisk Investigational Site, Lisboa, 1160-045, Portugal|Novo Nordisk Investigational Site, Lisboa, 1649-035, Portugal|Novo Nordisk Investigational Site, Porto, 4200-319, Portugal|Novo Nordisk Investigational Site, Badajoz, 06080, Spain|Novo Nordisk Investigational Site, Baracaldo, 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, Sevilla, 41013, Spain|Novo Nordisk Investigational Site, Zaragoza, 50009, Spain |
| URL: | https://clinicaltrials.gov/show/NCT00184769 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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