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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Chronic Kidney Disease

End-Stage Renal Disease

Healthy

Treatments

Drug: somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01502137

2005-000765-19 (EudraCT Number)

NN1630-1559

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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