Secondary Immunodeficiency (SID)NCT07868107
A Study of Secondary Immunodeficiencies in Adults With Blood Cancers in Kazakhstan Who Have a Weakened Immune System (K-SIDE Study)
An observational study of Secondary Immunodeficiency (SID), run by Takeda at 1 site in Kazakhstan.
Trial summary
Some people with blood cancers (hematologic malignancies) develop a weakened immune system because of their condition or the medicines used to treat it. This is called a secondary immunodeficiency or SID. A weakened immune system can make it harder for the body to fight infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Immunodeficiency (SID)
- How many people
- 200 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Apr 2027to 30 Sep 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants who have been diagnosed with HM and documented SID and/or evidence meeting the study SID definition. The participants must be treated at the National Oncology Center (Astana) with available EHR data in the Kazakhstan National Oncology Registry/EHR.
Who may be able to join
None listed.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Age <18 years.
- Primary immunodeficiency (PID) diagnosis.
- No available EHR data within the study observation period.
- Previous enrolment in a therapeutic investigational drug or device trial during the study observation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Director contact
Kazakhstan1 site
National Research Oncology Center
Astana, Z05T6H4
Site Contact, +7 (7172) 57-08-67, kense@cancercenter.kz
Azat Karabekov
About this study
Official title: Epidemiology, Clinical Burden, and Practice Patterns of Secondary Immunodeficiencies in Hematologic Malignancies: A Retrospective Analysis of Electronic Health Records in Kazakhstan
Some people with blood cancers (hematologic malignancies) develop a weakened immune system because of their condition or the medicines used to treat it. This is called a secondary immunodeficiency or SID. A weakened immune system can make it harder for the body to fight infections. SIDs make participants more likely to have serious infections, need treatment at a hospital, and need longer treatment periods with antibiotics. SIDs are common but often overlooked in people with blood cancers in Kazakhstan. Currently, Kazakhstan does not have national guidelines for diagnosing and managing SIDs, which leads to differences in how people are assessed and treated across healthcare settings.
The main aim of this study is to understand how common SIDs are in adults with blood cancers in Kazakhstan, which people are most affected and how often related health problems such as infections happen. Other aims are to learn more about SIDs in Kazakhstan: how SIDs are treated, how they affect a person's health and daily life (clinical burden) and how certain factors (such as age, health condition, treatment, type and stage of the blood cancer) may influence SIDs.
This study will not collect any new data. It will use existing health records and data from Kazakhstan's national oncology registry.
- Conditions
- Secondary Immunodeficiency (SID)
- Being tested
- No Intervention
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| HM participants with SID | Adult participants with a hematologic malignancy treated at the National Oncology Center (Astana) and recorded in the Kazakhstan National Oncology Registry/electronic health record (EHR) will be included. Eligible participants must have a documented diagnosis of SID and/or evidence meeting the protocol-defined SID criteria, defined by immunoglobulin (IgG) less than (<) 5 grams per liter (g/L), specific antibody failure, or severe/recurrent infections. Data from January 2021 until study start (estimated April 2027) will be evaluated. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Hematologic Malignancies Who Meet the Protocol-defined SID Criteria
The percentage of participants with hematologic malignancies who meet the protocol-defined SID criteria will be reported. SID is defined as IgG <5 g/L, proven specific antibody failure, and/or a history of severe or recurrent infections. Each participant will be assessed from the start of available EHR data until the earliest of the last available EHR, follow-up, death, or the retrospective data cut-off date. Cut-off date, is defined as the final date of data availability included in the study dataset, corresponding to the initiation of data extraction from the EHR/registry: all eligible participant data recorded in the EHR/registry up to and including this date will be considered for analysis.
Measured: Up to 6 years
Secondary outcomes (19)
Number of Infection Episodes During the Post-index Observation Period
Measured: Up to 6 years
Frequency of Infection Episodes During the Post-index Observation Period
Measured: Up to 6 years
Number of Participants Receiving Antibiotic or Antimicrobial Therapy
Measured: Up to 6 years
Overall Hospitalization Rate
Measured: Up to 6 years
Infection-related Hospitalization Rate
Measured: Up to 6 years
Number of Participants who had Intensive Care Unit (ICU) Admissions
Measured: Up to 6 years
Number of Participants With Emergency Department Visits
Measured: Up to 6 years
Length of Hospital Stay
Measured: Up to 6 years
Percentage of Participants With Hospital Readmission Within 30 Days
Measured: Up to 6 years
Duration of Receiving Intravenous (IV) or Subcutaneous (SC) Immunoglobulin Replacement Therapy (IgRT)
Measured: Up to 6 years
Number of Participants Receiving Prophylactic Antibiotics or Antivirals
Measured: Up to 6 years
Number of Diagnostic Tests and Monitoring Assessments for SID
Measured: Up to 6 years
Number of Participants Categorized by SID Severity
Measured: Up to 6 years
Number of Participants With Comorbidities
Measured: Up to 6 years
Number of Participants Categorized by Hematologic Malignancy Subtype
Measured: Up to 6 years
Number of Participants Categorized by Disease Characteristics
Measured: Up to 6 years
Number of Participants Categorized by Oncology Therapy Exposure
Measured: Up to 6 years
Number of Participants Categorized by Type of Oncology Therapy
Measured: Up to 6 years
Number of Participants Categorized by IgRT Subgroup
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Immunodeficiency (SID)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868107
- Sponsor's protocol ID
- TAK-771-4015
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Clinical Burden, and Practice Patterns of Secondary Immunodeficiencies in Hematologic Malignancies: A Retrospective Analysis of Electronic Health Records in Kazakhstan
- ClinicalTrials.gov ID
- NCT07868107
- Acronym / sponsor ID
- TAK-771-4015
- Conditions
- Secondary Immunodeficiency (SID)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some people with blood cancers (hematologic malignancies) develop a weakened immune system because of their condition or the medicines used to treat it. This is called a secondary immunodeficiency or SID. A weakened immune system can make it harder for the body to fight infections. SIDs make participants more likely to have serious infections, need treatment at a hospital, and need longer treatment periods with antibiotics. SIDs are common but often overlooked in people with blood cancers in Kazakhstan. Currently, Kazakhstan does not have national guidelines for diagnosing and managing SIDs, which leads to differences in how people are assessed and treated across healthcare settings.
The main aim of this study is to understand how common SIDs are in adults with blood cancers in Kazakhstan, which people are most affected and how often related health problems such as infections happen. Other aims are to learn more about SIDs in Kazakhstan: how SIDs are treated, how they affect a person's health and daily life (clinical burden) and how certain factors (such as age, health condition, treatment, type and stage of the blood cancer) may influence SIDs.
This study will not collect any new data. It will use existing health records and data from Kazakhstan's national oncology registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM participants with SID | – | Other: No InterventionAdult participants with a hematologic malignancy treated at the National Oncology Center (Astana) and recorded in the Kazakhstan National Oncology Registry/electronic health record (EHR) will be included. Eligible participants must have a documented diagnosis of SID and/or evidence meeting the protocol-defined SID criteria, defined by immunoglobulin (IgG) less than (<) 5 grams per liter (g/L), specific antibody failure, or severe/recurrent infections. Data from January 2021 until study start (estimated April 2027) will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants who have been diagnosed with HM and documented SID and/or evidence meeting the study SID definition. The participants must be treated at the National Oncology Center (Astana) with available EHR data in the Kazakhstan National Oncology Registry/EHR.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Age <18 years.
- Primary immunodeficiency (PID) diagnosis.
- No available EHR data within the study observation period.
- Previous enrolment in a therapeutic investigational drug or device trial during the study observation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | HM participants with SID |
Primary outcome
Percentage of Participants With Hematologic Malignancies Who Meet the Protocol-defined SID Criteria
Time frame: Up to 6 years
The percentage of participants with hematologic malignancies who meet the protocol-defined SID criteria will be reported. SID is defined as IgG <5 g/L, proven specific antibody failure, and/or a history of severe or recurrent infections. Each participant will be assessed from the start of available EHR data until the earliest of the last available EHR, follow-up, death, or the retrospective data cut-off date. Cut-off date, is defined as the final date of data availability included in the study dataset, corresponding to the initiation of data extraction from the EHR/registry: all eligible participant data recorded in the EHR/registry up to and including this date will be considered for analysis.
19 secondary outcomes
Number of Infection Episodes During the Post-index Observation Period
Time frame: Up to 6 years
Frequency of Infection Episodes During the Post-index Observation Period
Time frame: Up to 6 years
Number of Participants Receiving Antibiotic or Antimicrobial Therapy
Time frame: Up to 6 years
Overall Hospitalization Rate
Time frame: Up to 6 years
Infection-related Hospitalization Rate
Time frame: Up to 6 years
Number of Participants who had Intensive Care Unit (ICU) Admissions
Time frame: Up to 6 years
Number of Participants With Emergency Department Visits
Time frame: Up to 6 years
Length of Hospital Stay
Time frame: Up to 6 years
Percentage of Participants With Hospital Readmission Within 30 Days
Time frame: Up to 6 years
Duration of Receiving Intravenous (IV) or Subcutaneous (SC) Immunoglobulin Replacement Therapy (IgRT)
Time frame: Up to 6 years
Number of Participants Receiving Prophylactic Antibiotics or Antivirals
Time frame: Up to 6 years
Number of Diagnostic Tests and Monitoring Assessments for SID
Time frame: Up to 6 years
Number of Participants Categorized by SID Severity
Time frame: Up to 6 years
Number of Participants With Comorbidities
Time frame: Up to 6 years
Number of Participants Categorized by Hematologic Malignancy Subtype
Time frame: Up to 6 years
Number of Participants Categorized by Disease Characteristics
Time frame: Up to 6 years
Number of Participants Categorized by Oncology Therapy Exposure
Time frame: Up to 6 years
Number of Participants Categorized by Type of Oncology Therapy
Time frame: Up to 6 years
Number of Participants Categorized by IgRT Subgroup
Time frame: Up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Director contact
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Immunodeficiency (SID), run by Takeda at 1 site in Kazakhstan.
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 0 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. 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.
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?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Hematologic Malignancies Who Meet the Protocol-defined SID Criteria (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.