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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01502137
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; End-Stage Renal Disease; Healthy	Drug: somatropin; Drug: somatropin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESRD patients	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.
Experimental: Healthy subjects	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, subjects will receive 7 doses.

Outcome Measures

Primary Outcome Measures

1. Growth hormone exposure at steady state []

Secondary Outcome Measures

1. Area under the Curve (AUC) []

2. t½ (terminal half-life) []

3. Cmax (maximum plasma concentration) []

4. tmax (time to reach maximum) []

5. IGF-I (Insulin-Like Growth Factor I) []

6. Adverse events (AE) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	München		Germany	81241

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01502137
• Other Study ID Numbers: NN1630-1559; 2005-000765-19
• First Posted: Dec 30, 2011
• Last Update Posted: Jan 24, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Study Results

No Results Posted as of Jan 24, 2017