EUCTR2013-003354-24-NL
Active, not recruiting
Not Applicable
Influence of exogenous growth hormone administration on circulating levels of Klotho in healthy and CKD subjects
Vrij Universiteit Medical Center0 sitesOctober 8, 2014
ConditionsCardiovascular disease in chronic kidney diseaseTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
DrugsGenotropin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular disease in chronic kidney disease
- Sponsor
- Vrij Universiteit Medical Center
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Healthy patients without CKD, or patients with CKD stage III.
- •\-Patients \= 18 years and \< 65 years old.
- •\-Providing informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 20
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
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.
Outcomes
Primary Outcomes
Not specified
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