Malignant NeoplasmsPhase 2/3NADERIN-SSDNCT07671508
Prophylaxis of Complications of Basic Therapy Using Naderin in Socially Significant Diseases
A Phase 2/3 study testing Naderin and Standard Therapy in people with Malignant Neoplasms and Tuberculosis (TB), run by MIPO Clinic.
Trial summary
This interventional study evaluated the efficacy of Naderin (sodium nucleinate) for the prophylaxis of complications during basic therapy and medical rehabilitation in patients with socially significant diseases, including malignant neoplasms, tuberculosis, and hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Malignant Neoplasms, Tuberculosis (TB), HEPATITIS C (HCV)
- What is being tested?
- Naderin and Standard Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2013to 12 Mar 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of malignant neoplasm, tuberculosis, or hepatitis C (confirmed by clinical, laboratory, and/or histopathological criteria)
- Age between 18 and 50 years at the time of enrollment
- Receiving standard basic therapy (chemotherapy, anti-tuberculosis therapy, or antiviral therapy) according to national clinical protocols
- Signed informed consent to participate in the study
- Willingness to comply with study procedures and follow-up visits
- ECOG performance status ≤ 2 or equivalent
Who cannot join
- Severe concomitant diseases (e.g., decompensated cardiovascular, renal, or hepatic failure) that could interfere with study participation or outcome assessment
- Known hypersensitivity or contraindications to Naderin (sodium nucleinate) or its components
- Pregnancy or lactation
- Participation in any other interventional clinical trial within 30 days prior to enrollment
- Active or uncontrolled infections (other than the primary study condition)
- Severe immunodeficiency (e.g., HIV/AIDS, advanced hematological malignancies) not related to the primary study condition
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- Mental or cognitive impairment that would preclude informed consent or compliance with study procedures
- History of organ transplantation requiring immunosuppressive therapy
- Any other condition that, in the investigator's opinion, would make the participant unsuitable for the study
About this study
Official title: Prophylaxis of Complications of Basic Therapy and Medical Rehabilitation Using Naderin in Socially Significant Diseases, Including Malignant Neoplasms, Tuberculosis, and Hepatitis C
This interventional study evaluated the efficacy of Naderin (sodium nucleinate) for the prophylaxis of complications during basic therapy and medical rehabilitation in patients with socially significant diseases, including malignant neoplasms, tuberculosis, and hepatitis C. The study assessed the immunocorrective effects of Naderin on hematological parameters, the incidence of infectious complications, and clinical outcomes.
A total of 75 patients (40 in the main group and 35 in the control group) were enrolled. Patients in the main group received Naderin as an adjunct to standard therapy, while the control group received standard therapy without immunocorrection. The study demonstrated that Naderin reduced the duration of neutropenia by 4-5 days, attenuated the decline in white blood cell and lymphocyte counts during chemotherapy, and reduced the incidence of treatment interruptions due to complications. These findings suggest that Naderin may serve as an effective immunomodulatory agent for supportive care in patients with socially significant diseases.
Read the detailed description
Rationale Standard treatments for malignant neoplasms, tuberculosis, and hepatitis C may be associated with clinically important complications (e.g., cytopenias, immunosuppression, infections) that can impair treatment delivery and rehabilitation. Naderin (sodium nucleinate) was evaluated as an adjunct immunomodulatory/supportive-care approach intended to improve tolerance of basic therapy and reduce complication-related disruptions.
Study Design and Setting This was a prospective, controlled, open-label interventional study conducted at clinical sites affiliated with the Kazakh National Medical University (KazNMU), Almaty, Kazakhstan, supported by KazNMU Grant 2013. Allocation to intervention vs control was non-randomized (controlled cohort comparison).
Study Population and Groups (high-level)
A total of 75 participants with one of the following diagnostic categories were enrolled: malignant neoplasms, tuberculosis, or hepatitis C. Participants were assigned to:
- Intervention group: standard-of-care therapy for the underlying condition plus Naderin (immunocorrection).
- Control group: standard-of-care therapy without Naderin. (Condition-specific eligibility criteria and any stratification by disease category should be presented in the Eligibility Criteria and Study Design/Arms sections rather than repeated here.) Intervention (high-level description) Participants in the intervention group received Naderin (sodium nucleinate) as an adjunct to standard therapy. Key intervention specifications should be captured in the Arms/Interventions module (and/or here if not elsewhere): route, dose, frequency, timing relative to basic therapy, duration, and criteria for dose modification/discontinuation, consistent with protocol reporting standards for reproducibility 1.
Assessments and Follow-up
Participants underwent baseline and follow-up assessments during the active treatment/rehabilitation period that included:
- Hematology monitoring (e.g., WBC and lymphocyte counts; other CBC indices as applicable to the disease group and therapy).
- Clinical surveillance for infectious complications using predefined clinical criteria and documentation of antimicrobial treatment/hospitalization where relevant.
- Documentation of basic-therapy delivery (e.g., interruptions, delays, or discontinuation attributable to complications).
- Safety monitoring for adverse events temporally associated with adjunctive Naderin and with underlying disease therapy.
Outcomes (high-level; details elsewhere) The study evaluated hematologic parameters, infectious complications, treatment delivery disruption due to complications, and rehabilitation-related clinical outcomes. Outcome definitions, metrics, and time frames should be specified in the dedicated Outcome Measures section per SPIRIT guidance 1 and SPIRIT-Outcomes extension expectations for prespecification 2.
Statistical Approach (high-level) Between-group comparisons were planned using appropriate tests based on outcome type (categorical vs continuous) with a prespecified two-sided significance threshold. If subgroup analyses by disease category (neoplasm vs TB vs HCV) were planned, the analysis set and handling of multiplicity should be stated in the Statistical Analysis Plan or briefly here with a reference, consistent with SPIRIT expectations 1.
Ethics and Oversight The study received ethics approval from the Local Ethics Committee of KazNMU (Approval No. 15678). Written informed consent was obtained prior to enrollment. No data monitoring committee was constituted.
- Conditions
- Malignant Neoplasms, Tuberculosis (TB), HEPATITIS C (HCV)
- Being tested
- Naderin, Standard Therapy
- Keywords
- naderin, sodium nucleinate, immunocorrection, medical rehabilitation, socially significant diseases, oncology, tuberculosis, hepatitis c, immunomodulation, supportive care, neutropenia, chemotherapy complications, Kazakhstan, KazNMU
- Medical subject headings
- Neoplasms, Tuberculosis, Hepatitis C, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaderinDrug
Also called sodium nucleinate
Naderin (sodium nucleinate) is an immunomodulatory agent administered as an adjunct to standard basic therapy for the prophylaxis of complications. It enhances immune function, reduces the duration of neutropenia, and attenuates the decline in hematological parameters during chemotherapy and other aggressive therapies.
Standard TherapyOther
Standard basic therapy according to clinical protocols for malignant neoplasms, tuberculosis, and hepatitis C. Includes chemotherapy, anti-tuberculosis therapy, and antiviral therapy as per national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Naderin + Standard Therapy | Experimental | Participants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) in combination with Naderin (sodium nucleinate) as an adjunct immunocorrective therapy for the prophylaxis of complications. Receives: Drug: Naderin |
| Standard Therapy Alone | Active comparator | Participants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) without immunocorrection. Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Infectious Complications
The number and proportion of participants who developed infectious complications (e.g., pneumonia, febrile neutropenia, bacterial infections) during the course of basic therapy (chemotherapy, anti-tuberculosis therapy, antiviral therapy).
Measured: Up to 6 months (from study start to completion)
Duration of Neutropenia
The number of days participants experienced neutropenia (absolute neutrophil count < 1.0 × 10⁹/L) during the course of basic therapy.
Measured: Up to 6 months (from study start to completion)
Change in White Blood Cell (WBC) and Lymphocyte Counts
The change in white blood cell count (× 10⁹/L) and lymphocyte count (× 10⁹/L) from baseline to post-treatment assessment, comparing the Naderin group and control group.
Measured: Baseline and up to 6 months
Secondary outcomes (3)
Time to Recovery of Hematological Parameters
The number of days required for normalization of white blood cell count, lymphocyte count, and absolute neutrophil count after the completion of therapy.
Measured: Up to 6 months
Adverse Events Profile
The number and severity of adverse events (graded according to CTCAE criteria) experienced by participants in both groups.
Measured: Up to 6 months
Duration of Hospitalization
The total number of days participants were hospitalized during the course of therapy and follow-up
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 May 2013
- Primary completion21 Sep 2013
- Study completion12 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups were used in this study. Participants in the main group received Naderin (sodium nucleinate) as an adjunct to standard basic therapy, while participants in the control group received standard therapy without immunocorrection. The study was conducted at clinical sites affiliated with the Kazakh National Medical University (KazNMU), Almaty, Kazakhstan.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- MIPO Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671508
- Sponsor's protocol ID
- 6
- Other IDs
- Grant of KazNMU 2013
- Acronym
- NADERIN-SSD
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Complications of Basic Therapy and Medical Rehabilitation Using Naderin in Socially Significant Diseases, Including Malignant Neoplasms, Tuberculosis, and Hepatitis C
- ClinicalTrials.gov ID
- NCT07671508
- Acronym / sponsor ID
- NADERIN-SSD / 6
- Conditions
- Malignant Neoplasms, Tuberculosis (TB), HEPATITIS C (HCV)
- Keywords
- naderin, sodium nucleinate, immunocorrection, medical rehabilitation, socially significant diseases, oncology, tuberculosis, hepatitis c
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- MIPO ClinicUniversity, hospital or other
- Study start
- 15 May 2013 (actual)
- Primary completion
- 21 Sep 2013 (actual)
- Study completion
- 12 Mar 2014 (actual)
- First posted
- 26 Jun 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.
This interventional study evaluated the efficacy of Naderin (sodium nucleinate) for the prophylaxis of complications during basic therapy and medical rehabilitation in patients with socially significant diseases, including malignant neoplasms, tuberculosis, and hepatitis C. The study assessed the immunocorrective effects of Naderin on hematological parameters, the incidence of infectious complications, and clinical outcomes.
A total of 75 patients (40 in the main group and 35 in the control group) were enrolled. Patients in the main group received Naderin as an adjunct to standard therapy, while the control group received standard therapy without immunocorrection. The study demonstrated that Naderin reduced the duration of neutropenia by 4-5 days, attenuated the decline in white blood cell and lymphocyte counts during chemotherapy, and reduced the incidence of treatment interruptions due to complications. These findings suggest that Naderin may serve as an effective immunomodulatory agent for supportive care in patients with socially significant diseases.
Detailed description
Rationale Standard treatments for malignant neoplasms, tuberculosis, and hepatitis C may be associated with clinically important complications (e.g., cytopenias, immunosuppression, infections) that can impair treatment delivery and rehabilitation. Naderin (sodium nucleinate) was evaluated as an adjunct immunomodulatory/supportive-care approach intended to improve tolerance of basic therapy and reduce complication-related disruptions.
Study Design and Setting This was a prospective, controlled, open-label interventional study conducted at clinical sites affiliated with the Kazakh National Medical University (KazNMU), Almaty, Kazakhstan, supported by KazNMU Grant 2013. Allocation to intervention vs control was non-randomized (controlled cohort comparison).
Study Population and Groups (high-level)
A total of 75 participants with one of the following diagnostic categories were enrolled: malignant neoplasms, tuberculosis, or hepatitis C. Participants were assigned to:
- Intervention group: standard-of-care therapy for the underlying condition plus Naderin (immunocorrection).
- Control group: standard-of-care therapy without Naderin. (Condition-specific eligibility criteria and any stratification by disease category should be presented in the Eligibility Criteria and Study Design/Arms sections rather than repeated here.) Intervention (high-level description) Participants in the intervention group received Naderin (sodium nucleinate) as an adjunct to standard therapy. Key intervention specifications should be captured in the Arms/Interventions module (and/or here if not elsewhere): route, dose, frequency, timing relative to basic therapy, duration, and criteria for dose modification/discontinuation, consistent with protocol reporting standards for reproducibility 1.
Assessments and Follow-up
Participants underwent baseline and follow-up assessments during the active treatment/rehabilitation period that included:
- Hematology monitoring (e.g., WBC and lymphocyte counts; other CBC indices as applicable to the disease group and therapy).
- Clinical surveillance for infectious complications using predefined clinical criteria and documentation of antimicrobial treatment/hospitalization where relevant.
- Documentation of basic-therapy delivery (e.g., interruptions, delays, or discontinuation attributable to complications).
- Safety monitoring for adverse events temporally associated with adjunctive Naderin and with underlying disease therapy.
Outcomes (high-level; details elsewhere) The study evaluated hematologic parameters, infectious complications, treatment delivery disruption due to complications, and rehabilitation-related clinical outcomes. Outcome definitions, metrics, and time frames should be specified in the dedicated Outcome Measures section per SPIRIT guidance 1 and SPIRIT-Outcomes extension expectations for prespecification 2.
Statistical Approach (high-level) Between-group comparisons were planned using appropriate tests based on outcome type (categorical vs continuous) with a prespecified two-sided significance threshold. If subgroup analyses by disease category (neoplasm vs TB vs HCV) were planned, the analysis set and handling of multiplicity should be stated in the Statistical Analysis Plan or briefly here with a reference, consistent with SPIRIT expectations 1.
Ethics and Oversight The study received ethics approval from the Local Ethics Committee of KazNMU (Approval No. 15678). Written informed consent was obtained prior to enrollment. No data monitoring committee was constituted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups were used in this study. Participants in the main group received Naderin (sodium nucleinate) as an adjunct to standard basic therapy, while participants in the control group received standard therapy without immunocorrection. The study was conducted at clinical sites affiliated with the Kazakh National Medical University (KazNMU), Almaty, Kazakhstan.
| Arm | Type | Receives |
|---|---|---|
| Naderin + Standard Therapy | Experimental | Drug: NaderinParticipants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) in combination with Naderin (sodium nucleinate) as an adjunct immunocorrective therapy for the prophylaxis of complications. |
| Standard Therapy Alone | Active comparator | Other: Standard TherapyParticipants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) without immunocorrection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of malignant neoplasm, tuberculosis, or hepatitis C (confirmed by clinical, laboratory, and/or histopathological criteria)
- Age between 18 and 50 years at the time of enrollment
- Receiving standard basic therapy (chemotherapy, anti-tuberculosis therapy, or antiviral therapy) according to national clinical protocols
- Signed informed consent to participate in the study
- Willingness to comply with study procedures and follow-up visits
Key exclusion criteria (9 listed)
- Severe concomitant diseases (e.g., decompensated cardiovascular, renal, or hepatic failure) that could interfere with study participation or outcome assessment
- Known hypersensitivity or contraindications to Naderin (sodium nucleinate) or its components
- Pregnancy or lactation
- Participation in any other interventional clinical trial within 30 days prior to enrollment
- Active or uncontrolled infections (other than the primary study condition)
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 |
|---|---|---|
| NaderinAlso: sodium nucleinateNaderin (sodium nucleinate) is an immunomodulatory agent administered as an adjunct to standard basic therapy for the prophylaxis of complications. It enhances immune function, reduces the duration of neutropenia, and attenuates the decline in hematological parameters during chemotherapy and other aggressive therapies. | Drug | Naderin + Standard Therapy |
| Standard TherapyStandard basic therapy according to clinical protocols for malignant neoplasms, tuberculosis, and hepatitis C. Includes chemotherapy, anti-tuberculosis therapy, and antiviral therapy as per national guidelines. | Other | Standard Therapy Alone |
Primary outcome
Incidence of Infectious Complications
Time frame: Up to 6 months (from study start to completion)
The number and proportion of participants who developed infectious complications (e.g., pneumonia, febrile neutropenia, bacterial infections) during the course of basic therapy (chemotherapy, anti-tuberculosis therapy, antiviral therapy).
Duration of Neutropenia
Time frame: Up to 6 months (from study start to completion)
The number of days participants experienced neutropenia (absolute neutrophil count < 1.0 × 10⁹/L) during the course of basic therapy.
Change in White Blood Cell (WBC) and Lymphocyte Counts
Time frame: Baseline and up to 6 months
The change in white blood cell count (× 10⁹/L) and lymphocyte count (× 10⁹/L) from baseline to post-treatment assessment, comparing the Naderin group and control group.
3 secondary outcomes
Time to Recovery of Hematological Parameters
Time frame: Up to 6 months
Adverse Events Profile
Time frame: Up to 6 months
Duration of Hospitalization
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Naderin and Standard Therapy in people with Malignant Neoplasms and Tuberculosis (TB), run by MIPO Clinic.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of Infectious Complications (time frame: Up to 6 months (from study start to completion)). The study lists 3 primary outcomes in all. 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 30 Jun 2026.