Status:
COMPLETED
Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Chronic Kidney Disease
End-Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.
Eligibility Criteria
Inclusion
- PATIENTS:
- Male or female, age equal to or above 18 years undergoing chronic haemodialysis
- Stable and adequate haemodialysis treatment three months prior to enrolment
- HEALTHY SUBJECTS:
- Matching an individual of the patient group by: Gender and age (± 5 years)
- Matching an individual of the patient group by weight (after dialysis, ±10%)
- Creatinine clearance above 80 ml/min
- Subjects must be in good health in accordance with their age as determined by a medical
- history, physical examination, vital signs, ECG (electrocardiogram), routine haematology and clinical chemistry
Exclusion
- Use of cuprophane membranes
- Active malignant disease
- Diabetes
- Critical illness as defined by the need of respiratory or circulatory support
- Known or suspected allergy to the trial product
- Pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
- using inadequate contraceptive measures
- Blood Pressure (pre-dialysis) above 180/110
- Chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
- Treated with immunosuppressive agents
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01502137
Start Date
June 1 2005
End Date
November 1 2005
Last Update
January 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
München, Germany, 81241