Prophylaxis of Complications of Basic Therapy Using Naderin in Socially Significant Diseases (NADERIN-SSD)

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.

Study Overview

• Status: Completed
• Conditions: HEPATITIS C (HCV); Tuberculosis (TB); Malignant Neoplasms
• Intervention / Treatment: Drug: Naderin; Other: Standard Therapy

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naderin + Standard Therapy; 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.	Drug: Naderin; 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.; Other Names: sodium nucleinate
Active Comparator: Standard Therapy Alone; Participants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) without immunocorrection.	Other: Standard Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Baseline and up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 6 months
Duration of Hospitalization	The total number of days participants were hospitalized during the course of therapy and follow-up	Up to 6 months

Collaborators and Investigators

• Sponsor: MIPO Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2013
• Primary Completion (Actual): September 21, 2013
• Study Completion (Actual): March 12, 2014

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: oncology; neutropenia; tuberculosis; immunomodulation; supportive care; hepatitis c; Kazakhstan; medical rehabilitation; sodium nucleinate; naderin; immunocorrection; socially significant diseases; chemotherapy complications; KazNMU
• Additional Relevant MeSH Terms: Blood-Borne Infections; Cytopenia; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Leukocyte Disorders; Hematologic Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Leukopenia; Actinomycetales Infections; Mycobacterium Infections; Agranulocytosis; Hepatitis; Hemic and Lymphatic Diseases; Neoplasms; Hepatitis C; Tuberculosis; Neutropenia; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; sodium nucleinate
• Other Study ID Numbers: 6; Grant of KazNMU 2013 (Other Grant/Funding Number: KazNMU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No