Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fresenius Kabi
With
EastHORN Clinical Services in CEE
MLM Medical Labs GmbH
ALS Czech Republic, s.r.o.
PCG Clinical Services AB
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Written informed consent
2. Non-dialysed male and female CKD patients with expected start of dialysis ≥ 3 months
3. eGFR ≥5 to \< 30 ml/min/1.73 m2
4. Stable renal function at least 12 weeks before enrollment, defined by change in serum creatinine ≤ 80 µmol/L
5. Body mass index (BMI): ≥ 22 kg/m² and ≤ 35 kg/m2
6. Age: ≥ 40 to ≤ 75 years
7. Eligible physical status of the patient for participation in the study upon assessment of the investigator based on medical history, physical examination and clinical laboratory parameters
You may not be if
1. Existing gastrointestinal diseases or pathological findings (e.g. heart, liver, or lung failure), which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient (e.g. persistent or frequent episodes of anorexia, vomiting, or diarrhea)
18. Positive anti-HIV-test (if positive to be verified by western blot), Hepatitis B surface antigen (HBsAG)-test (if positive to be verified by test for hepatitis B core antigen (HBc)- Immunoglobulin M (IgM)) or anti-hepatitis C virus (HCV)-test
19. Current drug or alcohol dependence
20. Blood donation (including donation of plasma and platelets) or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the patient
21. Participation in an interventional clinical trial during the last 2 months prior to individual enrolment of the patient
22. Patients who report a frequent occurrence of migraine attacks (i.e. at least once per month)
23. History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
24. Change in habits of physical activity within the last 2 months for at least 7 days (e.g. immobilisation due to bed rest, immobilisation of a leg or other big muscle groups)
25. Positive pregnancy test at screening examination
26. Pregnant or lactating women
27. Not willing to apply highly effective contraceptive methods \[i.e. combined (estrogen and progestogen containing) hormonal contraception e.g. oral, intravaginal, transdermal and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) in combination with male condom; bilateral tubal occlusion, vasectomised partner or sexual abstinence\]
28. Patients suspected or known not to follow instructions
29. Patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
