Chronic kidney disease renal insufficiency
Conditions
Interventions
All subjects will be administered subcutaneous injections of Somatropin (=
rhGH) of 20 µg/kg/day for 7 subsequent days.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with CKD stage III, control group: patients without CKD. - Patients * 18 years and
Exclusion criteria
Exclusion criteria: - Patients who, in the opinion of the study investigator may present a safety risk. - Patients who are unlikely to adequately comply with the trial*s procedures (due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or non-compliance). - Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. growth hormone suppletion, thyroid hormone suppletion, use of estrogens, corticosteroids, androgens or anabole steroids, insulin). - Patients taking other experimental (i.e., non marketed) therapies within a month before preceding screening. - Patients with any pituitary disease. - Women who are pregnant, breastfeeding, intend to become pregnant, or not using or willing to use adequate contraception. - Unwillingness to comply with reproductive precautions. Women who are capable of becoming pregnant must be willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking the investigational product. - Known growth hormone deficiency. - History of any malignancy, or active current malignancy. - Active intracranial tumours. - BMI > 30. - History of respiratory disorders or obstructive sleep apnea syndrome (OSAS). - Critical illness as defined by the need for respiratory or circulatory support (e.g., in an intensive care unit). - Patients with thyroidal disease. - Treatment with immunosuppressive agents. - Patients with active vasculitis. - Patients with heart failure or a history of heart failure. - Severe hepatic disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal). - Severe chronic systemic infections or inflammatory disease. - Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg two times measured). - Active respiratory infection. - Patients with diabetes. - Patients with signs of malnutrition. - Patients with autosomal dominant polycystic kidney disease (ADPKD). - Patients with a single kidney. - Known or suspected allergy to trial product(s) or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To demonstrate the absolute change from baseline to day 7 in sKlotho levels in serum and urine before and after seven daily subcutaneous gifts of rhGH in patients with CKD stadium III and age-matched healthy controls. 2. To compare the difference in response between subjects with CKD stage III and age-matched healthy controls after 7 days of subcutaneous injection of rhGH on sKlotho levels in serum and urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed