LEVOCARNITINE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, LACTIC ACID, XYLITOL, POLYDEXTROSE for End-stage renal disease (ESRD)

Inclusion criteria

• {"criterion_text":"- Adults with End-Stage Kidney Disease\n- GFR ≥ 5\n- Patients in treatment with peritoneal dialysis for less than 6 months (at screening visit) and in stable clinical conditions\n- Patients in incremental PD treatment with 1 daily Icodextrin(7.5%)-based solution and 1 daily glucose (up to 1.5%)-based solution, according the IPD regimens allowed by the study (at screening and baseline visits)\n- Understand the nature and characteristics of the study and give informed consent to participate\n- Weekly Kt/V urea ≥ 1.7"}

Exclusion criteria

• {"criterion_text":"- Episode of peritonitis in the last 3 months\n- Hypersensitivity to any of the components of the study IMPs\n- History of primary hyperoxaluria\n- Patients with acute renal failure\n- Presence of contraindications to the use of Polydextrin-based peritoneal dialysis solutions: allergy to starch-based polymers, maltose or isomaltose intolerance, glycogen storage disease, pre-existing severe lactic acidosis\n- Patients with loss of peritoneal function or extensive adhesions compromising peritoneal function\n- patients with a history of abdominal surgery in the month preceding commencement of therapy, patients with abdominal fistulae, tumors, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface or intra-abdominal cavit\n- Uncorrectable mechanical defects that prevent effective PD or increase the risk of infection.\n- History of oxalate or lactate abnormalities considered clinically significant by the investigator\n- History or evidence of any other medical, neurological, or psychological condition that, in the clinical judgment of the investigator, would place the subject at undue risk of a significant AE or interfere with study assessments during the course of the tri\n- Enrolled in a clinical trial with an investigational product within 1 month before the start of the study\n- Suspected or history of drug and/or alcohol abuse\n- Severe pulmonary, cardiac, or hepatic disease/insufficiency\n- Clinically significant abnormal liver function tests (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)\n- Any type of active malignancy. Patients with excised basal cell carcinoma of the skin may be included\n- Female patients who are pregnant or breastfeeding, or women of childbearing potential who are not using or are refusing to use an adequate contraceptive program"}

Primary endpoints

• {"endpoint_text":"- Adverse Events (during the whole study)","definition_or_measurement_approach":"Continuous monitoring of adverse events throughout the whole study (primary objective: evaluate safety through continuous monitoring of adverse events, vital signs, and laboratory parameters)."}
• {"endpoint_text":"- Physical Examination (at every visit)","definition_or_measurement_approach":"Physical examinations performed at every visit."}
• {"endpoint_text":"- Vital Signs and body weight (at every visit)","definition_or_measurement_approach":"Assessment of vital signs and body weight at every visit."}
• {"endpoint_text":"- Blood chemistry and hematology (at every visit)","definition_or_measurement_approach":"Blood chemistry and hematology tests performed at every visit."}
• {"endpoint_text":"- 24h diuresis analysis (at every visit)","definition_or_measurement_approach":"24-hour urine output (diuresis) analysis at every visit."}
• {"endpoint_text":"- 24h dialysate analysis (at every visit)","definition_or_measurement_approach":"24-hour dialysate analysis at every visit."}
• {"endpoint_text":"- Weekly Kt/V urea (evaluated at every visit)","definition_or_measurement_approach":"Weekly Kt/V urea measurement evaluated at every visit."}
• {"endpoint_text":"- Residual kidney function (at every visit)","definition_or_measurement_approach":"Assessment of residual kidney function at every visit."}

Secondary endpoints

• {"endpoint_text":"- Post-baseline profile of weekly Kt/V urea (at every visit)","definition_or_measurement_approach":"Post-baseline weekly Kt/V urea profile assessed at every visit."}
• {"endpoint_text":"- Peritoneal ultrafiltration (at every visit and daily by patient diary)","definition_or_measurement_approach":"Peritoneal ultrafiltration measured at every visit and recorded daily by patient diary."}
• {"endpoint_text":"- Peritoneal and total sodium removal (at every visit)","definition_or_measurement_approach":"Peritoneal and total sodium removal assessments at every visit."}
• {"endpoint_text":"- Glycemic and lipidic parameters (at every visit)","definition_or_measurement_approach":"Measurement of glycemic and lipid parameters at every visit."}
• {"endpoint_text":"- Peritoneal clearances: creatinine, phosphate, B2-microglobulin, (at every visit)","definition_or_measurement_approach":"Peritoneal clearances for creatinine, phosphate, B2-microglobulin assessed at every visit."}
• {"endpoint_text":"- Quality of Life: KDQOL-SF (V2, V4)","definition_or_measurement_approach":"Quality of life assessed using KDQOL-SF (versions V2 and V4)."}
• {"endpoint_text":"- N° of patients who dropped-out from the study for safety and efficacy reasons","definition_or_measurement_approach":"Count of patients who dropped out for safety or efficacy reasons."}

Italy

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

351

Number Of Sites

7

Number Of Participants

28

Primary sponsor

Full Name

Iperboreal Pharma S.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Nubilaria S.r.l.","duties_or_roles":"codes: 10,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Romania","full_name":"Infomed Fluids S.R.L.","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Persongene S.r.l.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Clinpharma S.r.l.","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}