LEVOCARNITINE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, GLUCOSE MONOHYDRATE, SODIUM LACTATE for End-stage kidney disease

Inclusion criteria

• {"criterion_text":"- Male and female patients younger than 18 years old\n- Diagnosed with ESRD and in treatment with CAPD or APD for the last 6 months\n- L-carnitine plasma level ≤30 nmol/ml\n- Dwell volume from 800 ml/m2 to 1200 ml/m2 body surface\n- Have not experienced peritonitis episodes in the last 3 months\n- Provided written informed consent to participate in the study"}

Exclusion criteria

• {"criterion_text":"- Male and female patients ≥ 18 years old\n- Impeding/major abdominal surgery\n- Enrolment in another clinical trial involving medical or device based interventions during a) the 30 days before the screening or b) 5-times the halflife of the used investigational product (the longest period should be considered).\n- Ipersensibility to Glucose, L-Carnitine and other Glucothera Plus components\n- Evidence of any condition that, according to the investigators’ judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially affecting the study quality data.\n- Female patients who are pregnant or breast-feeding or women of childbearing potential* not receiving adequate contraceptive methods\n- Subjects with reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adesions\n- Uncontrolled hyperphosphatemia\n- Participation in a clinical trial with an investigational drug within one month prior start of study. Prior participation in this trial\n- Suspicion of drug abuse\n- Severe pulmonary, cardiac or hepatic disease/insufficiency\n- Clinically significant abnormal liver function test (Gamma-GT > 4 times the upper normal limit and/or transaminases (AST and/or ALT) > 3 upper normal limits)\n- Any kind of malignancy\n- Lack of appropriate caregiver support"}

Primary endpoints

• {"endpoint_text":"- Safety assesses on the basis of continuous Adverse Events reporting, including evaluation of blood pressure and weight","definition_or_measurement_approach":"Continuous adverse events reporting with monitoring/evaluation of blood pressure and weight"}

Secondary endpoints

• {"endpoint_text":"- Kt/V urea (V2 and V3)","definition_or_measurement_approach":"Kt/V urea measured at visits V2 and V3"}
• {"endpoint_text":"- 24h Peritoneal ultrafiltration (V2 and V3)","definition_or_measurement_approach":"24-hour peritoneal ultrafiltration measured at visits V2 and V3"}
• {"endpoint_text":"- 24h urinary volume (V2 and V3)","definition_or_measurement_approach":"24-hour urinary volume measured at visits V2 and V3"}
• {"endpoint_text":"- Peritoneal Equilibration Test (V2 and V3)","definition_or_measurement_approach":"Peritoneal Equilibration Test performed at visits V2 and V3"}
• {"endpoint_text":"- Residual Kidney Function (V2 and V3)","definition_or_measurement_approach":"Residual kidney function assessed at visits V2 and V3"}
• {"endpoint_text":"- Plasma L-carnitine (V1, V2 and V3)","definition_or_measurement_approach":"Plasma L-carnitine levels measured at visits V1, V2 and V3"}
• {"endpoint_text":"- Tolerability assessment - blood chemistry and hematology (V2, V3, V4)","definition_or_measurement_approach":"Tolerability assessed by blood chemistry and hematology panels at visits V2, V3 and V4"}

Italy

Earliest CTIS Part Ii Submission Date

23-02-2024

Latest Decision Or Authorization Date

08-04-2024

Processing Time Days

45

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Iperboreal Pharma S.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Clinpharma S.r.l.","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Industria Farmaceutica Galenica Senese S.r.l.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}