Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients

NCT03961009 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: KIG10_US3_PID01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).

Conditions

Primary Immunodeficiency Disease

Keywords

Immunoglobulin; Kedrion IVIg10%; IgG antibodies; Agammaglobulinemia; Hypogammaglobulinemia

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Acute Serious Bacterial Infections (ABSIs)

  Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria.

  Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

Secondary Outcomes (78)

• Serum Immunoglobulin G (IgG) Trough Levels

  At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)

• Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)

  At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

• Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria

  Up to 12 months

• Anti-Tetanus Toxoid Antibody Levels

  Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

• Anti-Pneumococcal Capsular Polysaccharide Antibody Levels

  Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)

Study Arms (1)

Kedrion IVIG 10%

EXPERIMENTAL

Participants received intravenous infusion of Kedrion IVIG 10% at a dose of 200 to 800 milligrams per kilogram (mg/kg) body weight on every 21 or 28 days for period of 48 weeks.

Biological: Kedrion IVIG 10%

Interventions

Kedrion IVIG 10% BIOLOGICAL

Kedrion intravenous immunoglobulin (IVIg) 10%

Kedrion IVIG 10%

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent/assent obtained from participant/participant's 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, requiring treatment with IVIg and have 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 \[that is at least 2 standard deviations under the mean level per age\])
• Male or female, ages 2 to 70 years at screening
• Received 200 to 800 mg/kg of a commercially available IVIg therapy in the range of 21- or 28-day intervals (±3 days or ±4 days, respectively) for at least 3 infusion cycles prior to screening
• At least 2 documented IgG trough levels while receiving an IVIg, of greater than or equals to (\>=) 6 gram per liter (g/L) obtained at 2 infusion cycles within 12 months (1 must be within 6 months) prior to Informed Consent Form (ICF) signature
• Participant is willing to comply all requirements of the protocol.
• Females of child-bearing potential with a negative urine pregnancy test and who agree to employ adequate birth control measures during the study
• Authorization to access personal health information
• Participant 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 infusion cycles (21 or 28 days) prior to screening
• Participant 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 infusion cycles (21 or 28 days) prior to screening

You may not qualify if:

• Newly diagnosed PID and 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 \[CD3+ \<300 cells per cubic millimeter (cell/mm3)\] and an absent or particularly low proliferative response \[10% of the lower normal range\] to phytohaemagglutinin P \[PHA\])
• Has history of severe or serious reactions or hypersensitivity to IVIg or other injectable forms of IgG
• Has 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 participant's lifetime
• Has IgA deficiency with documented antibodies to IgA
• Have received blood products that have not undergone viral inactivation measures within 12 months prior to Informed Consent Form (ICF) signature
• Has significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia
• Has an acute infection as documented by culture or diagnostic imaging and/or a body temperature \>= 38 degree Celsius (°C) (\>=100.4 degree Fahrenheit (°F) within 7 days prior to screening
• Has acquired immunodeficiency syndrome (AIDS) and/or hepatitis B/C active disease at ICF signature
• Has levels of 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
• Has profound anemia (haemoglobin less than10 gram per deciliter \[g/dl\]) or persistent severe neutropenia (\<= 1000 neutrophils per millimeter cube (mm\^3) or lymphopenia of less than 500 cells per microliter
• Have severe chronic condition such as renal failure (creatinine concentration \> 2.0 times the upper limit of normal) with proteinuria, 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, hyper viscosity, 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. Normal values for serum creatinine are the following: a) Female (18+ years): 45 - 84 micromole per liter (mcmol/L) or 0.51 - 0.95 milligrams per deciliter (mg/dl); b) Male (18+ years): 59 - 103 mcmol/L or 0.67 - 1.17 mg/dl
• Has 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
• Has history of pharmacoresistant epilepsy or multiple episodes of migraine (defined as at least 1 episode within 6 months of ICF signature) not completely controlled by medication

Sponsors & Collaborators

• Kedrion S.p.A.: lead

Study Sites (11)

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Dr. Henry J. Kanarek - Allergy, Asthma & Immunology

Overland Park, Kansas, 66211, United States

Location

Midwest Immunology Clinic and Infusion Center

Plymouth, Minnesota, 55446, United States

Location

Allergy and Immunology Associates

Little Silver, New Jersey, 07739, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Optimed Research

Columbus, Ohio, 43235, United States

Location

Ohio Clinical Research Associates, Inc.

Mayfield Heights, Ohio, 44124, United States

Location

Toledo Institute of Clinical Research Inc

Toledo, Ohio, 43617, United States

Location

Allergy Partners of North Texas Research

Dallas, Texas, 75230, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Agammaglobulinemia

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases

Results Point of Contact

• Title: Dr. Mirella Calcinai, MD, Clinical Research Director
• Organization: Kedrion S.p.A

m.calcinai@kedrion.com

+393486559761

Study Officials

• Medical Director

  Kedrion SpA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: April 30, 2019
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: May 5, 2026
• Results First Posted: January 27, 2022

Record last verified: 2026-04

Locations

US (11)