Objectives of KIDCARES10 Study (KIg10 in pediatric subjects: effiCacy, safety and phaRmacokinEticS of a 10% IG) a phase III, open-label, prospective, multi-center study are to assess the efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years and affected by primary immunodeficiency disease (PI)
The first patient was treated at Dipartimento di Scienze Mediche TraslazionaliUniversità Federico II in Napoli, Italy
KIDCARES10 will enroll 30 patients in 18 sites across five countries (Italy, Portugal, Hungary, Slovak Republic and Russia)
Results of KIDCARES10 will be submitted to the US Food and Drug Administration
FORT LEE, NJ, July 13, 2021 /PRNewswire/ — Kedrion Biopharma, an international biopharmaceutical company specialized in the manufacture and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, announced that the first patient has been treated in the KIDCARES10 (KIg10 in pediatric subjects: effiCacy, safety and phaRmacokinEticS of a 10% IG) clinical trial. The trial is set to occur across five countries.
The first patient has been treated in the KIDCARES10 clinical trial at a site located at the Dipartimento di Scienze Mediche Traslazionali Università Federico II in Napoli, Italy. Shown in photo, left to right: Dr. E. Toriello, Dr. G. Giardino, Prof. dr. C. Pignata, Dr. E. Cirillo, Dr. R. Principle
PI is a rare disease affecting approximately 250,000 people in the United States.
KIDCARES10 is a phase III, open-label, prospective, multi-center study that will assess efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years who are affected by primary immunodeficiency disease ( PI). PI, a rare disease affecting approximately 250,000 people in the United States, is a group of disorders in which a part of the body’s immune system is missing or does not function properly.
“The number of patients who require treatment for primary immune deficiency continues to grow as this rare and serious medical condition becomes more and more well recognized and diagnosed by healthcare professionals,” said Prof. Claudio Pignata Professore Ordinario di Pediatria and treating physician at the KIDCARES10 clinical site where the first patient has been treated. “Data produced by the KIDCARES10 study will be extremely important in advancing an even deeper understanding of primary immune deficiency in children. We are certainly pleased and proud to be participating in this important trial.”
dr. Emilia Cirillo is the University researcher of the team led by Prof. Claudio Pignata.
“Kedrion Biopharma remains committed to making meaningful contributions to advancing the world’s understanding of the science of certain rare and serious diseases,” said Novinyo Serge Amega, MD, head of US Medical Affairs at Kedrion Biopharma. “The KIDCARES10 study is a clear illustration of that commitment. It is particularly gratifying to be working toward helping children who are diagnosed with primary immune deficiency.”
According to analysts, the global plasma-derived immunoglobulin market is expected to exceed $18B by the end of 2025. Kedrion Biopharma is one of several companies that supply immunoglobulin therapies to patients in Italy and other locations around the world.
About the KIDCARES10 Trial
KIDCARES10 (KIg10 in pediatric subjects: effiCacy, safety and phaRmacokinEticS of a 10% IG), a phase III, open-label, prospective, multi-center study will assess the efficacy, safety, and pharmacokinetics of KIG10, a 10 percent intravenous immunoglobulin (IVIG), in pediatric patients aged 2 to 17 years and affected by primary immunodeficiency disease (PI) over a period of 13 months.
The primary efficacy objective of KIDCARES10 is to assess the efficacy of KIg10 administered to patients with PI to demonstrate that the rate of acute serious bacterial infections (ie, the mean number of acute serious bacterial infections per patient-year) is less than 1.0 to provide substantial evidence of efficacy from day 1 to week 51/52. The primary safety objective is to assess the safety of KIg10 in the overall study population from day 1 to week 51/52.
Pharmacokinetic objectives of KIDCARES10 are to: assess distribution, metabolism, and elimination of KIg10 total IgG, IgG subclasses, and antigen-specific IgGs at steady state in pediatric PI patients with different dosing schedules; evaluate through concentrations of total IgG and compare to through concentrations prior to the study entry.
The primary efficacy endpoint of KIDCARES10 is the incidence rate (ie, the mean number per patient-year) of acute serious bacterial infections [bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis] according to pre-specified criteria.
Primary safety endpoints of KIDCARES10 include clinical measures such as the incidence and seriousness of adverse events (AEs) within the study subject group, and changes in subjects’ vital signs, physical examinations, and laboratory measures (hematology, serum chemistry and urinalysis) from day 1 to week 51/52.
About Primary Immunodeficiency (PI)
Primary Immunodeficiency (PI) is an umbrella term for a group of more than 350 rare and chronic disorders in which part of the body’s immune system is either missing or not functioning properly. PI disorders are not contagious. Rather, they are caused by hereditary or genetic defects. PI can affect anyone, regardless of age or gender. Approximately 250,000 people are diagnosed with PI in the United States.
About Kedrion Biopharma
Kedrion Biopharma is a leading international biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders. Kedrion has special expertise in the treatment of rare diseases and in the manufacture of hyper-immune products such as anti-hepatitis B, anti-tetanus and anti-D for prophylaxis against Rh sensitization and subsequent Hemolytic Disease of the Fetus and Newborn. The company operates through a fully integrated business model from the collection of plasma in its own centers in North America to fractionation and production in its manufacturing facilities located in Italy, the United States and Hungary. Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,500 employees and a commercial presence in approximately 100 countries worldwide. Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at kedrion.com and kedrion.us.
kedrion.us (PRNewsphoto/Kedrion Biopharma)
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