NL-OMON40366
Completed
Phase 2
Influence of exogenous growth hormone administration on circulating levels of Klotho in healthy and chronic kidney disease subjects - Klotho & Growth hormone
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients with CKD stage III, control group: patients without CKD.
- •\- Patients \* 18 years and \< 65 years old.
- •\- Providing informed consent.
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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