Phase II RCT Statistical Support — Empagliflozin in Non-Diabetic CKD
Simulated Case Study
This case study uses simulated data to demonstrate the statistical methodology, analysis workflow, and reporting standards we apply to real client projects. No actual patient or institutional data is represented.
SAP · MMRM · CDISC ADaM · Interim Analysis
Confidentiality Notice
All data presented here is simulated and replicates the statistical structure of the original trial datasets. The sponsor name is anonymized. No identifiable patient data, randomization codes, or proprietary trial information is disclosed.
Trial Phase
Phase II RCT
Design
Double-blind, placebo-controlled, parallel-arm
Sites
5 sites across GCC (simulated)
Sample size
180 (90 per arm)
Primary endpoint
Annual eGFR slope over 52 weeks
Interim analysis
50% information fraction — O'Brien-Fleming
Project Overview
Gulf Clinical Research Partners (a UAE-based contract research organization) engaged Naggar Analytics to provide complete statistical support for a Phase II, multicenter, double-blind, placebo-controlled randomized trial evaluating empagliflozin 10mg in non-diabetic patients with Chronic Kidney Disease Stage G3a–G4. The trial ran across 5 investigator sites in Abu Dhabi, Dubai, and Riyadh over a 24-month recruitment period, enrolling 180 participants with 1:1 randomization.
Statistical deliverables included: (1) a fully pre-specified SAP defining analysis populations, primary and secondary estimands, and a Bonferroni-Holm multiplicity adjustment strategy; (2) a SAS-generated randomization scheme stratified by baseline eGFR and study site; (3) a pre-planned interim analysis at 50% information fraction with O'Brien-Fleming alpha spending and a DSMB-ready summary; (4) CDISC SDTM and ADaM datasets with annotated CRF; and (5) the complete final analysis report with all TFLs prepared to ICH E3 standards.
Statistical Deliverables
- ▹Statistical Analysis Plan (SAP) — primary/secondary estimands, analysis populations, multiplicity strategy (Bonferroni-Holm)
- ▹Randomization scheme — 1:1, stratified by baseline eGFR category & study site, permuted blocks (SAS PROC PLAN)
- ▹Interim analysis at 50% information fraction — O'Brien-Fleming alpha spending, DSMB-ready summary report
- ▹CDISC SDTM & ADaM datasets — annotated CRF, define.xml
- ▹Mock Table, Figure & Listing (TFL) shells — pre-specified prior to database lock
- ▹Primary endpoint analysis — Mixed Model for Repeated Measures (MMRM) for annual eGFR slope
- ▹Secondary endpoints — Kaplan-Meier + Cox proportional hazards for time-to-40%-eGFR-decline
- ▹Safety analysis — MedDRA-coded adverse event tables, incidence rates, exposure-adjusted rates
- ▹Missing data sensitivity — multiple imputation (Rubin's rules) + tipping point analysis
- ▹Final analysis report — ICH E3-structured statistical section, full TFLs