NCT01502137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

December 29, 2011

Last Update Submit

January 23, 2017

Conditions

Chronic Kidney DiseaseEnd-Stage Renal DiseaseHealthy

Outcome Measures

Primary Outcomes (1)

  • Growth hormone exposure at steady state

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

ESRD patients

EXPERIMENTAL
Drug: somatropin

Healthy subjects

EXPERIMENTAL
Drug: somatropin

Interventions

somatropinDRUG

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.

ESRD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

München, 81241, Germany

Location

Related 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, 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.

    PMID: 17634080RESULT

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2011

First Posted

December 30, 2011

Study Start

June 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

DE(1)