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

Healthy Clinical Trial

Official title:

An Open, Non-randomized, Single-centre, Parallel Group Trial Investigating the Steady-state Blood Concentration Profile and Effects of Once Daily Subcutaneously Injected Recombinant Human Growth Hormone (Norditropin® SimpleXx®) in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis and in Matched Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502137
• Other study ID #: NN1630-1559
• Secondary ID: 2005-000765-19
• Status: Completed
• Phase: Phase 1
• First received: December 29, 2011
• Last updated: January 23, 2017
• Start date: June 2005
• Est. completion date: November 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End-Stage Renal Disease
• Healthy
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• somatropin
Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, patients will receive 8 doses.
• somatropin
Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, subjects will receive 7 doses.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	München

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Langbakke IH, Nielsen JN, Skettrup MP, Harper A, Klitgaard T, Weil A, Engelhardt E, Lange M. Pharmacokinetics and pharmacodynamics of growth hormone in patients on chronic haemodialysis compared with matched healthy subjects: an open, nonrandomized, paral — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth hormone exposure at steady state
Secondary	Area under the Curve (AUC)
Secondary	t½ (terminal half-life)
Secondary	Cmax (maximum plasma concentration)
Secondary	tmax (time to reach maximum)
Secondary	IGF-I (Insulin-Like Growth Factor I)
Secondary	Adverse events (AE)

External Links

•   Clinical Trials at Novo Nordisk