| Trial ID: | L0960 |
| Source ID: | NCT01502137
|
| Associated Drug: |
Somatropin
|
| Title: |
Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|End-Stage Renal Disease|Healthy
|
| Interventions: |
DRUG: somatropin|DRUG: somatropin
|
| Outcome Measures: |
Primary: Growth hormone exposure at steady state | Secondary: Area under the Curve (AUC)|t½ (terminal half-life)|Cmax (maximum plasma concentration)|tmax (time to reach maximum)|IGF-I (Insulin-Like Growth Factor I)|Adverse events (AE)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-06
|
| Completion Date: |
2005-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-24
|
| Locations: |
Novo Nordisk Investigational Site, München, 81241, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01502137
|
