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

Phase 1

Completed

• Conditions: Chronic Kidney Disease; End-Stage Renal Disease; Healthy
• Interventions: Drug: somatropin

• Registration Number: NCT01502137
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESRD patients	somatropin	-
Healthy subjects	somatropin	-

Primary Outcome Measures

Name	Time	Method
Growth hormone exposure at steady state

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum plasma concentration)
Area under the Curve (AUC)
t½ (terminal half-life)
Adverse events (AE)
IGF-I (Insulin-Like Growth Factor I)
tmax (time to reach maximum)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 München, Germany