Prophylaxis of Complications of Basic Therapy Using Naderin in Socially Significant Diseases

NCT07671508 | Completed Phase 2

• 2 other identifiers: 6Grant of KazNMU 2013
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Malignant Neoplasms; Tuberculosis (TB); HEPATITIS C (HCV)

Keywords

naderin; sodium nucleinate; immunocorrection; medical rehabilitation; socially significant diseases; oncology; tuberculosis; hepatitis c; immunomodulation; supportive care; neutropenia; chemotherapy complications; Kazakhstan; KazNMU

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Time to Recovery of Hematological Parameters

  Up to 6 months

• Adverse Events Profile

  Up to 6 months

• Duration of Hospitalization

  Up to 6 months

Study Arms (2)

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.

Drug: Naderin

Standard Therapy Alone

ACTIVE COMPARATOR

Participants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) without immunocorrection.

Other: Standard Therapy

Interventions

Naderin DRUG

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.

Also known as: sodium nucleinate

Naderin + Standard Therapy

Standard Therapy OTHER

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.

Standard Therapy Alone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MIPO Clinic: lead

MeSH Terms

Conditions

Neoplasms; Tuberculosis; Hepatitis C; Neutropenia

Interventions

sodium nucleinate; Standard of Care

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor masked to group assignment; participants, care providers, investigators not masked (open-label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: May 15, 2013
• Primary Completion: September 21, 2013
• Study Completion: March 12, 2014
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share