Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodi… (NCT01502137) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis
Germany21 participantsStarted 2005-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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