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Immunoglobulin

Immunoglobulin for Primary Immunodeficiency (KIDCARES10 Trial)

Phase 3

Recruiting

Led By Chiara Azzari

Research Sponsored by Kedrion S.p.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females with a body weight ≥15 kg

Confirmed clinical diagnosis of a PID as defined by 2017 IUIS and ESID criteria and requiring treatment with IVIg

Must not have

Significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia

Newly diagnosed PID and naïve to IgG replacement therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Summary

This trial aims to determine how well and safely Kedrion Immunoglobulin 10% works in children with Primary Immunodeficiency Disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of IVIG treatments can include headache, fever, chills, fatigue, nausea, and in rare cases more serious reactions like allergic responses or blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 15 kg.

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I have a diagnosed primary immunodeficiency that needs IVIg treatment.

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I've had 3 or more IVIg treatments between 200 to 800 mg/kg.

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I have had two IgG levels above 6 g/L in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition causing significant protein loss.

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I have a new diagnosis of PID and haven't started IgG therapy.

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I do not have active AIDS or hepatitis B/C at the time of consent.

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I have had blood clots in the past.

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I have received blood products that were not treated for viruses within the last year.

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I haven't had a fever or infection in the last week.

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I do not have severe conditions like kidney failure or heart issues.

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I have epilepsy that doesn't respond to medication or I often have migraines.

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I have a specific immune system disorder affecting my antibodies or T-cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence Rate of Acute Serious Bacterial Infections

Secondary study objectives

Anti-Haemophilus influenza type b antibody level

Anti-measles antibody level

Anti-pneumococcal capsular polysaccharide antibody level

+13 more

Side effects data

From 2014 Phase 3 trial • 45 Patients • NCT01581593

29%

Upper Respiratory Tract Infection

27%

Headache

27%

Investigations

24%

Sinusitis

24%

Pyrexia

22%

Cough

18%

Fatigue

18%

Diarrhoea

16%

Back Pain

13%

Skin and subcutaneous tissue disorders

11%

Viral Upper Respiratory Infection

11%

Oropharyngeal Pain

11%

Asthma

Rhinitis

Vomiting

Nasal Congestion

Sinus Headache

Nausea

Insomnia

Metabolism and nutrition disorders

Eye Disorders

Myalgia

Bronchitis

Nasopharyngitis

Acute Sinusitis

Gastroenteritis Viral

Urinary Tract Infection

Immune System Disorders

Vascular Disorders

Rhinorrhoea

Sneezing

Adverse drug reaction

Arthralgia

Pain in extremity

Contusion

Lymphadenopathy

Bacterial pneumonia

Herpes zoster

Infective exacerbation of bronchiectasis

Bipolar disorder

Humerus Fracture

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Kedrion IVIG 10%

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human immunoglobulin G

FDA approved

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kedrion S.p.A.Lead Sponsor

6 Previous Clinical Trials

137 Total Patients Enrolled

Chiara AzzariPrincipal InvestigatorAzienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer - Italy

~9 spots leftby Apr 2026

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