Study of Genome-associated Mechanisms of Diabetic Nephropathy and Evaluation of Nephroprotective Therapy in Patients With Type 2 Diabetes Mellitus in the Kazakh Population
Conditions: Diabetes Mellitus, Diabetic Nephropathy
Sponsor: Astana Medical University

PROTOCOL WITH STATISTICAL ANALYSIS 
PLAN 
Official Title: 
Study of Genome-associated Mechanisms of Diabetic Nephropathy and Evaluation of 
Nephroprotective Therapy in Patients With Type 2 Diabetes Mellitus in the Kazakh 
Population 
Unique Protocol ID: AP25794125 
NCT Number: Pending 
Document Date: June 17, 2025 
 
 

1. Introduction 
This Statistical Analysis Plan (SAP) describes the planned statistical analyses for the study 
titled 'Study of Genome-associated Mechanisms of Diabetic Nephropathy and Evaluation of 
Nephroprotective Therapy in Patients With Type 2 Diabetes Mellitus in the Kazakh 
Population'. This SAP is designed in accordance with good clinical practice and regulatory 
guidelines. 
2. Study Objectives and Endpoints 
Primary Endpoint: 
- Improvement in estimated glomerular filtration rate (eGFR) after nephroprotective 
therapy. 
Secondary Endpoints: 
- Reduction in albuminuria levels 
- Genetic polymorphism associations with therapeutic outcomes 
- Change in serum creatinine levels 
3. Study Design and Population 
This is a prospective, observational study involving 100 patients with Type 2 Diabetes 
Mellitus and 75 control participants, all of Kazakh ethnicity, aged between 18 and 65 years. 
Both males and females will be included. 
4. Statistical Methods 
Statistical analyses will be performed using IBM SPSS Statistics 21. Descriptive statistics 
(mean, standard deviation, median, interquartile range) will be used to summarize the data. 
Comparisons between groups will be conducted using Student’s t-test or Mann-Whitney U 
test for continuous variables, and Chi-square test for categorical variables. Regression 
analyses (linear and logistic) will be used to identify predictors of therapeutic response. 
5. Stratification and Subgroup Analyses 
Subgroup analyses will be performed by age group, sex, baseline renal function, and genetic 
polymorphism profiles. 
6. Sample Size Justification 
A total sample size of 175 participants (100 patients and 75 controls) was chosen based on 
feasibility and expected effect size. This sample size is deemed sufficient to detect clinically 
meaningful differences with adequate statistical power. 

7. Interim Analysis 
An interim analysis will be conducted after 50% of the participants complete the study 
procedures. The results will be reviewed for safety and efficacy signals. 
8. Data Handling and Confidentiality 
All collected data will be de-identified and stored securely for a period of 3 years. Only 
study personnel will have access.