Overview

Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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