Influence of growth hormone administered subcutaneously on circulating Klotho levels in healthy subjects and subjects with renal failure.

• Conditions: Cardiovascular disease in chronic kidney disease; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-003354-24-NL
• Lead Sponsor: Vrij Universiteit Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-08
• Last Update Posted: 12 January 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
-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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.<br>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.<br>;Secondary Objective: Not applicable.;Primary end point(s): 1. The absolute change in sKlotho levels in serum and urine before and after a single subcutaneous gift of rhGH in patients with CKD stadium III-IV and matched controls.<br>2. Compare sKlotho levels in serum and urine before and after a single subcutaneous gift of rhGH in patients with CKD stadium III-IV with matched controls.;Timepoint(s) of evaluation of this end point: After the study is completed, so after 2 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): We also take a look at parameters of phosphate handling like<br>Serum chemistry: phosphate, albumin, calcium, FePI%<br>Urinalysis: TmP/GFR, FePI%, phosphate, calcium, albumin<br>;Timepoint(s) of evaluation of this end point: After the study is completed, so after 2 weeks.