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