| Trial ID: | L1471 |
| Source ID: | NCT01479088
|
| Associated Drug: |
Cinacalcet Hcl
|
| Title: |
Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Secondary Hyperparathyroidism
|
| Interventions: |
DRUG: Cinacalcet HCl
|
| Outcome Measures: |
Primary: Composite EP, e.g. the proportion of patients who will have a reduction from baseline of >= 25% in mean iPTH levels with concomitant values for plasma P <6 mg/dL and Ca between 8.4 and 10.5 mg/dL or the Ca x P product <60, This composite EP will address the needed information on the appropriate dose of cinacalcet to be adopted in paediatric patients, and especially in younger children, as well as on the impact of treatment with calcimimetics on serum Ca and P levels, and on SHPT control over the long term, 6 months | Secondary: The long term control of iPTH level < 300 pg/mL, 18 months|The long term control of PTH, Ca, P, and the Ca x P product values, 18 months|The PK/ PD ( iPTH and testosterone) profile at individual patient level, 12 months|The long term auxological indices and patient growth velocity during cinacalcet treatment, 18 months|The proportion of patients with treatment-emergent adverse events (AEs), serious AEs (SAEs), and laboratory abnormalities over long term, 18 months
|
| Sponsor/Collaborators: |
Sponsor: ENRICO VERRINA
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-03
|
| Completion Date: |
2013-12
|
| Results First Posted: |
|
| Last Update Posted: |
2011-11-24
|
| Locations: |
U.O. Nefrologia e Dialisi- Ospedale Giovanni XXIII, Bari, 70100, Italy|U.O. Nefrologia e Dialisi - Istituto di Ricovero e Cura a Carattere Scientifico Giannina Gaslini, Genoa, 16147, Italy|U.O. Nefrologia e Dialisi Pediatrica - Clinica De Marchi, Milan, 20100, Italy|U.O. Nefrologia e Dialisi - Ospedale Santobono, Naples, 80100, Italy|U.O. Nefrologia e Dialisi - Ospedale Bambino Gesù, Rome, 00100, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01479088
|
