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Primary Immunodeficiency DiseasePhase 3KIDCARES10NCT04944979

Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)

A Phase 3 study testing Kedrion IVIG 10% in people with Primary Immunodeficiency Disease, run by Kedrion S.p.A. at 21 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 2 to 16 years
Conditions the study is for
Primary Immunodeficiency Disease
What is being tested?
Kedrion IVIG 10%
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
21 sitesin 6 countries
Study dates
31 Mar 2021to May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent/assent obtained from the patient and his/her parent(s) or legally acceptable representative indicating that they understand the purpose of and procedures required for the study and are willing to participate in it.
  • Confirmed clinical diagnosis of a PID as defined by 2017 International Union of Immunological Societies (IUIS) Phenotypic Classification for Primary Immunodeficiencies (Bousfiha A, 2018 - and subsequent revisions) and The European Society for Immunodeficiencies (ESID) Registry Working Definitions for the Clinical Diagnosis of Inborn Errors of Immunity (Seidel MG et al., 2019 - and subsequent revisions) and requiring treatment with IVIg. Documented agammaglobulinemia (defined as the total absence of one or more classes of antibodies) or hypogammaglobulinemia (defined as low levels of one or more classes [i.e., at least 2 standard deviations under the mean level per age]).
  • (NOTE: IVIg treatment is generally requested in the absence of IgG independently from whether other antibodies are absent).
  • Male or female, age from 2 up to < 16 years, at the time of screening.
  • Received 200 to 800 mg/kg of a commercially available IVIg therapy in the range of 21- or 28-day intervals (±3 or ±4 days, respectively) for at least 3 infusions prior to screening.
  • (NOTE: Other IVIgs will be prohibited after ICF signature and until study end, week 51/52).
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  • At least 2 documented IgG trough levels while receiving an IVIg, of ≥ 6 g/L obtained at 2 infusions within 12 months (1 must be within 6 months) prior to ICF signature.
  • Patient and his/her parent(s)/legal guardian(s) are willing to comply with all requirements of the protocol.
  • Females of child-bearing potential with a negative pregnancy test (serum or urine) and who agree to employ adequate birth control measures during the study, such as:
  • sexual abstinence, to be evaluated in relation to the preferred and usual lifestyle of the subject;
  • male or female condom with or without spermicide;
  • cap, diaphragm or sponge with spermicide;
  • progestogen-only oral hormonal contraception, if already used in the past on medical prescription.
  • Adequate birth control measures should be maintained throughout the study under parental control.
  • Authorization to access personal health information.
  • Patients previously participating in a clinical trial with another experimental IVIg may be enrolled if they have received stable commercially available IVIg therapy for at least 3 infusions (21 or 28 days) prior to screening.
  • Patients currently on treatment with any subcutaneous immunoglobulin (SCIG) can be enrolled if they are switched to stable commercially available IVIg therapy for at least 3 infusions (21 or 28 days) prior to screening.
  • Males or females with a body weight greater than or equal to 15 kg (≥ 15 kg).

Who cannot join

  • Newly diagnosed PID and naïve to IgG replacement therapy.
  • Dysgammaglobulinemia (defined as a deficiency in one or more classes of antibodies, but not severe enough to require substitutive therapy) or isolated IgG subclass deficiency, or profound primary T cell deficiency (defined as the absence or severe reduction of T lymphocytes [CD3+ < 300 cell/mm3] and an absent or particularly low proliferative response [10% of the lower normal range] to phytohaemagglutinin P [PHA]).
  • History of severe or serious reactions or hypersensitivity to IVIg or other injectable forms of IgG.
  • History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction, as defined by at least 1 event in patient's lifetime.
  • IgA deficiency with documented antibodies to IgA.
  • Received blood products that have not undergone viral inactivation measures within 12 months prior to ICF signature.
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  • Significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
  • An acute infection as documented by culture or diagnostic imaging and/or a body temperature ≥38.5 °C (≥101.3 °F) within 7 days prior to screening.
  • Acquired immunodeficiency syndrome (AIDS) and/or hepatitis B/C active disease at ICF signature.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times of the upper limit of normal for the laboratory designated for the study.
  • Using an implanted venous access device.
  • Moderate or severe anemia, defined according to patient's age as shown in the following table (World Health Organization, 2011) or persistent severe neutropenia (≤ 500 neutrophils per mm3) or persistent lymphopenia of less than 500 cells per microliter.
  • A severe chronic condition such as renal failure [defined as abnormalities in kidney structure or function that are present for more than 3 months and have health implications. The disease is classified on the basis of cause and category of glomerular filtration rate (GFR) (G1 to G5) and albuminuria (A1 to A3) (KIDIGO, 2017). See the following table], congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity, or any other condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.
  • History of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to ICF signature.
  • History of pharmacoresistant epilepsy or multiple episodes of migraine (defined as at least 1 episode within 6 months of ICF signature) not controlled by medication.
  • Patient must not be receiving the following medication from at least 30 days prior to ICF signature:
  • Steroids, inhaled, oral or parenteral, at a daily dosage of ≥ 0.15 mg/kg/day of prednisone or equivalent).
  • Other immunosuppressive drugs (including monoclonal antibodies) or chemotherapy.
  • Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study.
  • Participated in another clinical study within 30 days prior to ICF signature.
  • Active drug or alcohol abuse or history of drug or alcohol abuse within the 6 months before screening.
  • Direct relative of an employee of the CRO, the study site, or Kedrion.
  • Previously treated under this protocol.
  • Unable to provide informed consent.
  • Patients with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives or the patient's participation in this trial.
  • Patients with Hypersensitivity to the active substance or to any of the excipients.

Trial locations and contacts

21 sites in 6 countries.

21 sites in 6 countries

United States8 sites

  • IMMUNOe Health and Research Centers

    Centennial, Colorado, 80112

  • Duke Children's Hospital & Health Center

    Durham, North Carolina, 27706

  • Velocity Clinical Research - MedPharmics - Lafayette

    Lafayette, Louisiana, 70508

  • Benioff Children&#39;s Hospital - Mission Bay

    San Francisco, California, 94158

  • Louisiana State University Shreveport

    Shreveport, Louisiana, 71103

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

  • Asthma and Allergy Center - Toledo

    Toledo, Ohio, 43617

  • Vital Prospects Clinical Research Institute PC

    Tulsa, Oklahoma, 74136

Other trials in United States

Italy7 sites

  • SST Spedali Civili di Brescia

    Brescia

  • Azienda Ospedaliero-Universitaria - Ospedale Pediatrico Meyer

    Florence

  • I.R.C.C.S. Istituto Giannina Gaslini

    Genova

  • Fondazione IRCCS Ca&#39; Granda Ospedale Maggiore Policlinic

    Milan

  • Azienda Ospedaliera Universitaria &#34;Federico II&#34;

    Naples

  • Fondazione Policlinico Tor Vergata

    Roma

  • IRCCS Ospedale Pediatrico Bambino Gesù

    Roma

Other trials in Italy

Portugal2 sites

  • Centro Hospitalar Lisboa Central - Hospital Dona Estefânia

    Lisbon

  • Centro Hospitalar Universitário do Porto - Hospital Santo António

    Porto

Other trials in Portugal

Russia2 sites

  • Children&#39;s City Clinical Hospital No. 9 named after G.N. Speransky, Moscow City Health Department

    Moscow

  • Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology

    Moscow

Other trials in Russia

Hungary1 site

  • Dél-Pesti Centrumkórház - Országos Hematológiai És Infektológiai Intézet

    Budapest

Other trials in Hungary

Slovakia1 site

  • Národný ústav detských chorôb (National Institute of Pediatric Diseases)

    Bratislava

Other trials in Slovakia

About this study

Official title: A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID)

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).

Being tested
Kedrion IVIG 10%
Keywords
Immunoglobulin, Kedrion IVIG 10%, IgG Antibodies, Agammaglobulinemia, Hypogammaglobulinemia, Pediatric
Medical subject headings
Primary Immunodeficiency Diseases, Agammaglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kedrion IVIG 10%Biological

    Kedrion intravenous immunoglobulin (IVIg) 10%

Study groups in NCT04944979
Study groupRoleWhat they receive
Experimental: Kedrion IVIG 10%ExperimentalParticipants 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.
Receives: Biological: Kedrion IVIG 10%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Rate of Acute Serious Bacterial Infections

    Incidence rate (i.e., the mean number of acute serious bacterial infections per patientyear) of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) according to pre-specified criteria).

    Measured: From Baseline (Day 1) up to week 51/52

Secondary outcomes (45)

  1. Serum Immunoglobulin G (IgG) trough levels

    Measured: Before each infusion of KIg10 and at the study termination visit (Week 51/52)

  2. Immunoglobulin G (IgG) subclasses levels (IgG1, IgG2, IgG3, IgG4)

    Measured: Before infusions 1, 5, 9 and 13 for the 28-day infusion schedule, and before infusions 1, 7, 11 and 17 for the 21-day infusion schedule

  3. Frequency of patients with total Immunoglobulin G (IgG) below 6 g/L

    Measured: Day 1 up to week 51/52

  4. Anti-tetanus toxoid antibody level

    The quantitative evaluation will be reported

    Measured: Before infusions 1, 5, 9 and 13 for the 28-day infusion schedule and before infusions 1, 7, 11 and 17 for the 21-day infusion schedule

  5. Anti-pneumococcal capsular polysaccharide antibody level

    The quantitative evaluation will be reported

    Measured: Before infusions 1, 5, 9 and 13 for the 28-day infusion schedule and before infusions 1, 7, 11 and 17 for the 21-day infusion schedule

  6. Anti-measles antibody level

    The quantitative evaluation will be reported

    Measured: Before infusions 1, 5, 9 and 13 for the 28-day infusion schedule and before infusions 1, 7, 11 and 17 for the 21-day infusion schedule

  7. Anti-Haemophilus influenza type b antibody level

    The quantitative evaluation will be reported

    Measured: Before infusions 1, 5, 9 and 13 for the 28-day infusion schedule and before infusions 1, 7, 11 and 17 for the 21-day infusion schedule

  8. Incidence rate (i.e., the mean number per patient-year) of any infection other than acute serious bacterial infections

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  9. Duration of any infection other than acute serious bacterial infections

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  10. Incidence rate (i.e. the mean number per patient-year) of fever episodes

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  11. Duration of fever episodes

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  12. Overall hospitalization days

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  13. Days of hospitalizations due to infection

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  14. Incidence rate (i.e. the mean number per patient-year) of patient on antibiotics for the treatment of any kind of infection

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  15. Duration of patients on antibiotics for the treatment of any kind of infection

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  16. Days of missed work/school/other major activities due to infections

    Information reported by participant/participant's parent(s)/legal guardian(s) in the Patient Diary, provided starting from the first infusion.

    Measured: From day 1 to week 51/52

  17. Pediatric Quality of Life Inventory (Pedsql) Score

    The PedsQL™ Measurement Model is a modular approach to measuring health-related QoL in healthy children and adolescents and those with acute and chronic health conditions. The 23-item PedsQL™ Generic Core Scales were designed to measure the core dimension of health as delineated by the World Health Organization, as well as role (school) functioning.

    The total scale score (23 items) consists of Physical health summary score (8 items) and Psychosocial health summary score (15 items). Physical health summary includes Physical Functioning (8 items) and Psychosocial health summary score includes Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). The overall range for PedsQL scores is 0 to 100, with a higher score indicating better quality of life.

    Measured: At baseline, week 24, and study termination visit

  18. Number of Adverse Events (%) and proportion of patients experiencing at least one Adverse Event (AE)

    Measured: From Baseline (Day 1) up to Week 51/52

  19. Number of Serisous AEs (%) and proportion of patients experiencing at least one Serious Adverse Event (SAE)

    Measured: From Baseline (Day 1) up to Week 51/52

  20. Number of related infusion AEs (%) occurring during infusion or within 1, 24, and 72 hours after the end of infusion, and proportion of patients experiencing at least one related infusion AE. at least 1 of such related infusion AE.

    Measured: From Baseline (Day 1) up to Week 51/52

  21. The proportion and number of KIg10 infusions for which the infusion rate is decreased due to Adverse Events.

    Measured: From Baseline (Day 1) up to Week 51/52

  22. Number and proportion of infusions with one or more infusion (temporally-associated) Adverse Event.

    Measured: From Baseline (Day 1) up to Week 51/52

  23. Number of Participants with Changes from Baseline Values in Vital Signs, Physical Examinations, Safety Laboratory Tests (hematology, serum chemistry and urinalysis).

    Number of participants with changes from baseline in vital signs (including blood pressure, heart rate and temperature); Physical examination (including evaluation of all body systems, body weight, height and Tanner Staging); Safety Laboratory Tests (including hematology, serum chemistry, and urinalysis) will be reported.

    Measured: Up to Week 51/52

  24. The proportion and number of patients with a positive Coomb's test

    Measured: Following infusion 7 for the 28-day infusion schedule and infusion 9 for the 21-day infusion schedule

  25. The proportion and number of patients with a positive urine hemosiderin test

    Measured: Following infusion 7 for the 28-day infusion schedule and infusion 9 for the 21- day infusion schedule

  26. Serum haptoglobin level

    Measured: Following infusion 7 for the 28-day infusion schedule and infusion 9 for the 21-day infusion schedule.

  27. Serum Total Immunoglobulin G (IgG) levels, IgG Subclasses Levels, and Selected Specific Antibody Levels

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  28. Plasma Concentration - Time Curve Of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  29. Elimination Half-Life (t1/2) of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  30. Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  31. Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC[0-inf]) of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  32. Volume of Distribution of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  33. Maximum Observed Plasma Concentration (Cmax) Of Total IgG

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  34. Time to Reach the Maximum Plasma Concentration (Tmax) of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  35. Elimination Rate Constant of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  36. Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-Tau) of Total Immunoglobulin G (IgG)

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  37. Plasma Concentration-Time Curve Of Specific Immunoglobulin G (IgG) Antibodies

    The quantitative evaluation of the anti-Tetanus toxoid, anti-pneumococcal capsular polysaccharide, anti-Haemophilus influenza type B and anti-measles antibodies level will be reported

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  38. Elimination Half-Life (t1/2) of Specific IgG Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  39. Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Specific Immunoglobulin G (IgG) Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  40. Volume Of Distribution of Specific Immunoglobulin G (IgG) Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  41. Maximum Observed Plasma Concentration (Cmax) of Specific Immunoglobulin G (IgG) Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  42. Time to Reach the Maximum Plasma Concentration (Tmax) of Specific Immunoglobulin G (IgG) Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  43. Elimination Rate Constant of Specific Immunoglobulin G (IgG) Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  44. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Specific Immunoglobulin G (IgG) Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

  45. Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-Tau) of Specific Immunoglobulin G (IgG) Antibodies

    Measured: Before and after infusion 5 (28-day infusion schedule) or infusion 7 (21-day infusion schedule)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start31 Mar 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944979
Sponsor's protocol ID
KB070
Acronym
KIDCARES10
Status last verified
May 2026
First submitted
11 Jun 2021
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Kedrion IVIG 10% in people with Primary Immunodeficiency Disease, run by Kedrion S.p.A. at 21 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Italy, Portugal, Russia, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Acute Serious Bacterial Infections (time frame: From Baseline (Day 1) up to week 51/52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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