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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.