Influence of exogenous growth hormone administration on circulating levels of Klotho in healthy and chronic kidney disease subjects

Phase 2

Completed

• Conditions: Chronic kidney disease; renal insufficiency; 10029149

• Registration Number: NL-OMON40366
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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.
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To demonstrate the absolute change from baseline to day 7 in sKlotho levels<br /><br>in serum and urine before and after seven daily subcutaneous gifts of rhGH in<br /><br>patients with CKD stadium III and age-matched healthy controls.<br /><br>2. To compare the difference in response between subjects with CKD stage III<br /><br>and age-matched healthy controls after 7 days of subcutaneous injection of rhGH<br /><br>on sKlotho levels in serum and urine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>