E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cardiovascular disease in chronic kidney disease |
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E.1.1.1 | Medical condition in easily understood language |
Heart- and vesseldiseases in patients with kidney failure. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy patients without CKD, or patients with CKD stage III. - Patients ≥ 18 years and < 65 years old. - Providing informed consent.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the study is completed, so after 2 weeks. |
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E.5.2 | Secondary end point(s) |
We also take a look at parameters of phosphate handling like Serum chemistry: phosphate, albumin, calcium, FePI% Urinalysis: TmP/GFR, FePI%, phosphate, calcium, albumin
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the study is completed, so after 2 weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
open, prospective, single-center, nonrandomized, single-arm, explorative stud |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |