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

Primary Purpose

Chronic Kidney Disease, End-Stage Renal Disease, Healthy

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
somatropin
somatropin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESRD patients

Healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

Growth hormone exposure at steady state

Secondary Outcome Measures

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

Full Information

First Posted
December 29, 2011
Last Updated
January 23, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01502137
Brief Title
Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End-Stage Renal Disease, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESRD patients
Arm Type
Experimental
Arm Title
Healthy subjects
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Growth hormone exposure at steady state
Secondary Outcome Measure Information:
Title
Area under the Curve (AUC)
Title
t½ (terminal half-life)
Title
Cmax (maximum plasma concentration)
Title
tmax (time to reach maximum)
Title
IGF-I (Insulin-Like Growth Factor I)
Title
Adverse events (AE)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
81241
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17634080
Citation
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, parallel-group trial. Clin Endocrinol (Oxf). 2007 Nov;67(5):776-83. doi: 10.1111/j.1365-2265.2007.02962.x. Epub 2007 Jul 18.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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