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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01502137

Enrollment

Registered

2011-12-30

Start date

2005-06-30

Completion date

2005-11-30

Last updated

2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, End-Stage Renal Disease, Healthy

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.

Interventions

DRUGsomatropin

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Growth hormone exposure at steady state	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026