Immunoglobulin for Primary Immunodeficiency
(KIDCARES10 Trial)
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Kedrion S.p.A.
Must be taking: IVIg
Must not be taking: Steroids, Immunosuppressives
Disqualifiers: AIDS, Hepatitis B/C, Renal failure, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking steroids at a daily dosage of 0.15 mg/kg/day or more of prednisone (a type of steroid) and other immunosuppressive drugs at least 30 days before starting the trial. Other IVIg treatments are also not allowed after signing the consent form.
What data supports the effectiveness of the drug Kedrion IVIG 10% for primary immunodeficiency?
Research shows that intravenous immunoglobulin (IVIG) treatments, like Kedrion IVIG 5%, are effective and safe for children with primary immunodeficiency, reducing severe infections. Additionally, a study on a 10% IVIG formulation found it effective in patients with primary immunodeficiency, suggesting similar benefits for Kedrion IVIG 10%.
12345Is immunoglobulin treatment generally safe for humans?
Immunoglobulin treatments, like Kedrion IVIG 10% and others, are generally considered safe, but they can cause side effects in some people. Serious side effects have been reported, affecting the kidneys, heart, skin, and blood, and the risk can depend on factors like age, health conditions, and the specific product used. It's important for doctors to carefully consider these risks and benefits before prescribing.
678910What makes Kedrion IVIG 10% unique for treating primary immunodeficiency?
Kedrion IVIG 10% is a concentrated intravenous immunoglobulin (IVIG) treatment specifically designed for primary immunodeficiency, offering a higher concentration compared to some other IVIG options like Kedrion 5%. This allows for potentially fewer infusions and a more convenient treatment schedule for patients.
12111213Eligibility Criteria
This trial is for children and teens aged 2 to under 18 with Primary Immunodeficiency Disease (PID) who need IVIg treatment. They must have a confirmed diagnosis, documented low antibody levels, and have been on stable IVIg therapy before joining. Participants also need consent from parents or guardians and agree to follow the study rules.Inclusion Criteria
I weigh at least 15 kg.
Written informed consent/assent obtained from the patient and his/her parent(s) or legally acceptable representative indicating understanding of the study purpose and procedures
Documented agammaglobulinemia or hypogammaglobulinemia
+9 more
Exclusion Criteria
Using an implanted venous access device
I have epilepsy that doesn't respond to medication or I often have migraines.
I have a new diagnosis of PID and haven't started IgG therapy.
+19 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 mg/kg body weight every 21 or 28 days
48 weeks
Infusions every 21 or 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The KIDCARES10 study is testing the effectiveness, safety, and how the body processes Kedrion Immunoglobulin 10% (KIg10), an intravenous treatment for kids with PID. The trial involves regular infusions of this medication over time.
1Treatment groups
Experimental Treatment
Group I: Experimental: Kedrion IVIG 10%Experimental Treatment1 Intervention
Participants will receive intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 milligram per kilogram (mg/kg) body weight every 21 or 28 days for period of 48 weeks.
Kedrion IVIG 10% is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Kedrion IVIG 10% for:
- Primary Immunodeficiency Disease (PID)
- Chronic Immune Thrombocytopenic Purpura (ITP)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
🇪🇺 Approved in European Union as Kedrion IVIG 10% for:
- Primary Immunodeficiency Disease (PID)
- Chronic Immune Thrombocytopenic Purpura (ITP)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
IMMUNOe Health and Research CentersCentennial, CO
Velocity Clinical Research - MedPharmics - LafayetteChula Vista, CA
Benioff Children's Hospital - Mission BaySan Francisco, CA
Vital Prospects Clinical Research Institute PCTulsa, OK
More Trial Locations
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Who Is Running the Clinical Trial?
Kedrion S.p.A.Lead Sponsor
References
Efficacy and safety of human intravenous immunoglobulin 5% (Ig VENA) in pediatric patients affected by primary immunodeficiency. [2021]Patients affected by primary immunodeficiencies are characterized for high susceptibility for severe infections. Our data demonstrate Kedrion 5% intravenous immunoglobulin G (IVIg) treatment effective and safe as replacement therapy for children and adolescents affected by primary immunodeficiency. The particularities of our study are the selection of a long period of follow-up (71 patient-years of follow-up), and to the best of our knowledge, our study is one of few that assesses the safety and efficacy of intravenous immunoglobulin treatment of primary immunodeficiency specifically in a pediatric population.
Intravenous and subcutaneous immunoglobulin replacement: a two-way road. Optimizing healthcare quality in patients with primary immunodeficiencies. [2021]To evaluate the alternate use of subcutaneous immunoglobulin (SCIG) and intravenous immunoglobulin (IVIG) in patients with primary immunodeficiencies (PID) in a third-level Pediatric University Hospital.
Efficacy and quality of life assessment in the use of subcutaneous immunoglobulin treatment for children with primary immunodeficiency disorder. [2022]Label="Summary"> Introduction. Most patients with primary and secondary immunodeficiencies need regular Intravenous Immunoglobulin (IVIG) or Subcutaneous Immunoglobulin (SCIG) treatment. This study aimed to evaluate the serum IgG trough levels, frequency of mild and severe infections, frequency and duration of hospitalization, duration of absence of school, and quality of life in patients switching their IVIG therapy to SCIG administration. Materials. Twenty-nine patients with immunodeficiency on regular IVIG treatment and who agreed to receive SCIG treatment were included. Seven patients discontinued treatment after the first SCIG administration. We collected data regarding serum IgG levels, annual numbers of infections, hospital admissions, and adverse events prior to and following SCIG initiation. PedsQL tests such as Scale Total Score (STS), Physical Health Total Score (PHTS), Psychosocial Health Total Score (PsyHTS), emotional functionality, social functionality, school/work problems score were calculated separately for all patients and their parents. Results. In twenty-two cases who were diagnosed as primary immunodeficiency, the most common indication for initiation of SCIG treatment was the long transfusion period of IVIG treatments and the difficulty of access to the hospital. No systemic side effects were noted except local redness, pain, and swelling on the injection site. The median IgG value was 588.9 mg/dl during IVIG treatment and 872 mg/dl one year after SCIG treatment. Annual frequency of infections and absence to school/work decreased significantly in the SCIG group while the annual number of hospitalizations and hospital stay time did not change significantly. There was a significant increase in the "quality of life" scores of the patients and their families. Conclusions. SCIG treatment provides ideal and protective immunoglobulin levels and offers the comfort of treatment in their home environment, thus increasing the patient's satisfaction and quality of life.
Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency. [2022]An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites.
The Experiences of Children with Primary Immunodeficiency Who Receive Immunoglobulin Subcutaneously Instead of Intravenously. [2023]Children with primary immunodeficiency disorder have begun receiving subcutaneous immunoglobulin (SCIg) instead of intravenous immunoglobulin (IVIg). So, we aim to explore the experiences of primary immunodeficiency children with regard to receiving SCIg instead of IVIg.
Risks associated with the use of intravenous immunoglobulin. [2022]Although US immune globulin intravenous (human) (IGIV) products have been regarded as safe, it is important to recognize that many of the controlled clinical studies of IGIVs have been of modest size and have limited power to define the incidence of only the most common adverse events (AEs). A significant number of "postmarketing" serious AEs affecting renal, cardiovascular, CNS, integumentary, and hematologic organ systems have been reported. Variables potentially affecting the risk and intensity of adverse events associated with administration of IGIV include patient age, underlying condition, history of migraine, cardiovascular or renal disease, dose, concentration, rate of infusion, specific brand/formulation/excipients, and lot(s) of the particular IGIV product being administered. Each manufacturer's IGIV preparation is a unique product carrying its own specific evidence-based indications and safety profile. In view of the seriousness of potential adverse effects of IGIV products, and current lack of data surrounding their frequency, clinicians are advised to limit their prescription of these products for conditions for which efficacy is supported by adequate and well-controlled clinical trials. Prescribers should pay close attention to patient selection; consider the potential risk/benefit ratio vis-a-vis alternate therapies; and familiarize themselves with the identification, management, and proposed strategies to minimize the risks of IGIV.
[Human immunoglobulins, adverse drug reaction, prevention]. [2016]Adverse drug reactions occur during 10% of immunoglobulin treatment. Risk factor of adverse drug reactions have been identified.
[Suspected adverse reactions after vaccination. Results from the German Health Interview and Examination Survey for Children and Adolescents. Part I: descriptive analyses]. [2016]The decreasing incidence of vaccine-preventable infectious diseases and their complications redirects public attention to the safety risks of vaccinations. Collation of resilient vaccine adverse reaction data from passive and active surveillance systems as well as epidemiological studies is indispensable. From 2003-2006, the representative National Health Interview and Examination Survey for Children and Adolescents ("Kinder- und Jugendgesundheitssurvey," KiGGS) retrospectively collected information about vaccines, vaccination dates, and suspected vaccine-related adverse events. A total of 15,958 participants (
Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season. [2020]Safety surveillance is required for each season's influenza vaccines to rapidly detect and evaluate potential new safety concerns before the peak period of immunization. Here we report the results of an enhanced passive safety surveillance for a trivalent split-virion inactivated influenza vaccine (IIV3; Vaxigrip®), an intradermal version of this vaccine (IIV3-ID; Intanza® 15 µg), and a recently licensed quadrivalent version (IIV4; VaxigripTetraTM) during the 2017/18 influenza season in the UK and Republic of Ireland. The primary objective was to determine the rates of adverse reactions (ARs) occurring within 7 days following routine vaccination. Between September and November 2017, 979 safety report cards were distributed to vaccinees receiving IIV3-ID, 1005 to those receiving IIV3, and 957 to those receiving IIV4. At least one AR was reported by 28 participants (2.9%) vaccinated with IIV3-ID, 14 participants (1.4%) vaccinated with IIV3, and 20 participants (2.1%) vaccinated with IIV4. The most frequent ARs were injection-site reactions and headache. One participant vaccinated with IIV3-ID reported two suspected serious ARs (dyskinesia and a shock symptom), although these could not be confirmed as vaccine-related. Rates of ARs for IIV3 and IIV3-ID for 2017/18 did not differ from the 2016/17 rates. For IIV4, in its first season since licensure, AR frequencies were similar to those in the Summary of Product Characteristics. In conclusion, no change was found compared to the known or expected AR rates for IIV3, IIV3-ID, or IIV4 during the 2017/18 season.
Incidence and costs of adverse drug reactions in a tertiary care pediatric intensive care unit. [2013]Adverse drug reactions (ADRs) increase morbidity, mortality, and hospital costs in children treated in the Pediatric Intensive Care Unit (PICU). Few studies have reported the incidence and risk factors of ADRs in PICU. Our study aimed to evaluate incidence, risk factors, and economic burden of ADRs in PICU. An intensive ADR surveillance was conducted at the PICU of Children's Hospital of Michigan between November 1, 2010 and May 31, 2011. A trigger list was used to screen for suspected ADR cases. Of the 697 consecutive PICU admissions reviewed, 13.1% experienced at least one episode of ADR. The ADR incidence was 22% in patients with cardiovascular (CV) surgery and 11.5% in other patients. The most frequently detected ADR was electrolyte imbalance associated with diuretic exposure. Mean age at admission was 4 years (interquartile range: 9 months-13 years). Risk factors for ADR included young age (
Subcutaneous immunoglobulin therapy for adult patients with primary immunodeficiency disease: Qatar experience. [2023]Label="INTRODUCTION" NlmCategory="BACKGROUND">Subcutaneous immunoglobulin (SCIG) and intravenous immunoglobulin (IVIG) are used for the treatment of primary immunodeficiency (PIDD). SCIG is as effective as IVIG in preventing infections.1 However, SCIG has advantages over IVIG as it causes fewer systemic reactions and can be infused at home by the patient leading to improved quality of life.2 Methods: We retrospectively analyzed adult patients with PIDD who received SCIG in an Adult Allergy Clinic in Qatar. Patients who received IVIG before SCIG and are naïve to IgG replacement were included. We compared Serum IgG levels, the number of antibiotic courses received, and the number of hospital admissions one year before and one year after starting SCIG. SF36 score was used to compare health-related quality of life scores before SCIG and after one year of SCIG.
Intravenous immunoglobulin 10% in children with primary immunodeficiency diseases. [2019]Label="AIM">To assess the safety and efficacy of an intravenous immunoglobulin (IVIG) 10% preparation (Panzyga®; Octapharma AG, Lachen, Switzerland) in predominantly antibody-deficient children with primary immunodeficiency disease.
Treatment of primary immunodeficiency with Kiovig: a literature review. [2010]Primary immunodeficiency disorders are associated with increased patient susceptibility to recurrent infections. Since the 1950s, immunoglobulin products have been administered to treat infections in primary immunodeficiency, and patients often require lifelong therapy. The aim of this study is to carry out a literature review of a ready-to-use 10% liquid immunoglobulin preparation, Kiovig (Baxter, Brussels, Belgium), in the treatment of primary immunodeficiency.