Kidney transplantation. MedDRA version: 14.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Cardiotrophin-1
Product Code: CT-1
Pharmaceutical Form: Solution for perfusion of organs
INN or Proposed INN: Cardiotrophin
CAS Number: NA
Current Sponsor code: CT-1
Other descriptive na
Sponsors
Digna Biotech S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A donor will be suitable only if all of the following criteria apply: 1.Heart-beating donors (male or female); 2.Donor aged ? 60 or donor aged 50-59 years and fulfilling 2 of the following 3 criteria: a.Serum creatinine more than 1.5 mg/dl. b.Death due to cerebrovascular accident. c.History of high blood pressure. A patient (Kidney recipient) will be eligible only if all of the following criteria apply: 1.Males or females aged 18 to 70 years without restricted legal competence and being able to comply with the study requirements. 2.Females of Childbearing Potential must have a negative urine pregnancy test at Screening/Treatment visit and must be willing to use one medically approved form of birth control while on study and for at least 28 days after taking kidney transplant. 3.Subject capable of giving written 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: A donor will not be suitable if any of the following criteria apply: 1.Infection by HIV, HBV and/or HCV viruses. 2.Non-heart beating donors. 3.Kidney from a living donor. 4.Cold ischemic time >24 hours. 5.Incompatible AB0 type with recipient. 6.Positive crossmatch with recipient. 7.Kidney maintained by pulsatile machine perfusion. A patient (recipient) will not be eligible if any of the following criteria apply: 1.Previous or current myelodysplastic or proliferative disorders. 2.History of cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma in situ. 3.Administration of any investigational drug in the period 0 to 90 days before entry to the study. 4.Pregnant or breastfeeding women. 5.Patient is scheduled to undergo multiorgan transplantation. 6.Chronic or ongoing active infectious disease requiring systemic treatment. 7.Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria. 8.Significant concurrent, uncontrolled medical condition including, but not limited to, hepatic, cerebrovascular, haematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric disease, or evidence of demyelinating disease or concurrent sepsis or active bacterial infection. 9.Any other condition which in the principal investigator?s opinion would make patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of CT-1 on kidney function after transplant through the incidence of functional Delayed Graft Function (fDGF).;Secondary Objective: ?To assess the effect of CT-1 on kidney function after transplant through: -The DGF rate, defined as the need of dialysis during the first week after transplantation. -The glomerular filtration rate post-transplant. -Serum creatinine levels post-transplant. ?The incidence and severity of acute rejection within 30 days post-transplant. ?To assess kidney damage by measuring the levels of serum and urine biomarkers. ?To assess the economic impact of CT-1 on kidney transplant. through the days of hospitalization after transplant. ?To assess the safety of CT-1 in kidney transplant.;Primary end point(s): Incidence of Delayed Graft Function (DGF) measured as a failure of the serum creatinine to decrease by at least 10% daily on 3 consecutive days during the first week after transplant, irrespective of dialysis requirements, but discounting creatinine decrements because of dialysis itself.;Timepoint(s) of evaluation of this end point: 1 week after kidney transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?DGF rate defined as the need of dialysis during the first week after transplantation. ?Estimated glomerular filtration rate (eGFR*) at post-transplant at days 1, 3, 5, 7, 14 and 30 post-trasplant. *Calculated according to ?Modification of diet in renal disease equation for glomerular filtration rate (MDRD)? ?Number of dialysis sessions through Day 7, 14, and 30. ?Mean serum creatinine at Days 1, 3, 5, 7, 14, and 30. ?Incidence and severity of biopsy-proven acute rejection within 30 days. ?At days 1, 3, 5, 7 and 14; there will be determined the levels of serum neutrophil gelatinase-associated lipocalin (S-NGAL) and urine markers such as total protein, albumin, cystatin C, beta-2 microglobulin, kidney injury molecule (KIM-1), clusterin (CLU), trefoil factor 3 (TTF 3), NGAL (U-NGAL), Ganglioside M2 activator protein (GM2AP), regenerating islet-derived protein III beta (Reg IIIb) and gelsolin. Additional serum and urine markers could be determined according to the AKI state of the art. ?Days of hospitalization. ?The investigator will assess the safety based on AEs and the laboratory evaluation across the study.;Timepoint(s) of evaluation of this end point: 30 days post-trasplant | — |
Countries
Spain
Contacts
Public ContactTrial Manager
Digna Biotech S.L.
Outcome results
None listed