Table of Contents
CARDIO-RENAL Advisory Committee Meeting
Baxter Participants
Consultants
Extraneal Development Milestones
Proposed Indication
Topics Identified in FDA Briefing Document & Questions
AGENDA Cardio-Renal Advisory Committee NDA 21-321 Extraneal (7.5% icodextrin)
Icodextrin: A Polymer of Glucose
Composition of Extraneal
Clinical Rationale for Extraneal
Unmet Clinical Need Limitations of Current Fluid Management in PD
Limitations of Fluid Management in PD Hampered by Inflexibility
The long dwell: an integral component of PD
Rationale for the long dwell in PD: Intersection of two imperatives
Limitations of Current Osmotic Agents Dextrose Kinetics in PD: Rapid Dissipation
Limitations of Current Osmotic Agents Balance of opposing forces
Limitations of Current Osmotic Agents: Temporal Decline
Limitations of Current Osmotic Agents Glycemic Effect of 4.25% Dextrose
Limitations of Current Osmotic Agents Hyperinsulinemic Effect of 4.25% Dextrose
Contrasting Dextrose vs. Icodextrin Peritoneal Kinetics
Plasma Levels of Total Icodextrin & Maltose Extraneal 035 Study – APD
Contrasting Dextrose vs. Icodextrin Net UF Profile Temporal Decline vs. Sustained Effect
Plasma Glucose and Insulin During an Extraneal Dwell (060 Study)
Rationale for Extraneal
Clinical Trial Experience with Extraneal Efficacy and Safety
Presentation Plan
Key Studies
Supportive Studies
Age, Gender and Race Integrated Summary of Safety — Baseline Demographics for All Studies
Primary Renal Diagnosis Integrated Summary of Safety — Baseline Demographics for All Studies
Efficacy Endpoints
Ultrafiltration Extraneal 130 Study — CAPD 8-16 hour Dwell, Mean Net UF – Change from Baseline
Ultrafiltration Extraneal 035 Study — APD 12-16 Hour Dwell, Mean Net UF – Change from Baseline
Ultrafiltration Extraneal MIDAS Study — CAPD 8 & 12-Hour Dwell 1.5% Dextrose, Mean Net UF – Change from Baseline
Ultrafiltration Extraneal MIDAS Study — CAPD 8 & 12-Hour Dwell 4.25% Dextrose, Mean Net UF – Change from Baseline
Percentage of Patients with Negative Net UF Extraneal 130 Study — CAPD 8-16 Hour Dwell
Percentage of Patients with Negative Net UF Extraneal 035 Study — APD 12-16 Hour Dwell
Percentage of Patients with Negative Net UF Extraneal MIDAS Study — CAPD 8-Hour Dwell & 12-Hour Dwell 1.5% Dextrose
Percentage of Patients with Negative Net UF Extraneal MIDAS Study — CAPD 8-Hour Dwell & 12-Hour Dwell 4.25% Dextrose
Efficacy Endpoints
Clearance of Creatinine & Urea Extraneal 130 Study — CAPD
Special Assessments from Long-term Study 131
Peripheral Edema Assessment Extraneal 131 Study — CAPD & APD
Adverse Events for Edema Extraneal 131 Study — CAPD & APD
Special Assessments from Study 131
Body Weight
Body Weight – Before Drain Extraneal 131 Study — CAPD & APD (N=47 Control, N=88 Extraneal)
Special Assessments from Long-term Study 131
Quality of Life — KDQoL Extraneal 131 Study — CAPD & APD
Quality of Life — KDQoL Results - SF36
Quality of Life — KDQOL Extraneal 131 Study — CAPD & APD
Extraneal Efficacy Conclusions
Safety Profile of Extraneal
Extraneal Clinical Database
Patient Disposition (Withdrawals/Completions, All Studies)
Safety Profile of Extraneal
Observational Mortality Extraneal 131 Study: Original Data Collection
Observational Mortality Extraneal 131 Study: Additional Data Collection
All Follow-Up Time for Mortality Extraneal Study 131: Long-Term Safety Study in APD and CAPD Patients
Observational Mortality All Studies (Other Than MIDAS-2)
Observational Mortality All Studies (Other Than MIDAS-2)
Kaplan-Meier Survival Curves for Time to Death Using All Mortality From ISS Except MIDAS-2 (Uncontrolled)
Observational Mortality Summary
Safety Profile of Extraneal
Extraneal All Studies Safety - Adverse Events
Adverse Events
Adverse Events
Adverse Events
Total Skin Events Incidence Rates – All Studies, Unrelated and Related AEs
Total Skin Events Incidence Rates – All Studies, Related AEs
Outcomes for Rash in Clinical Trials
Safety Profile of Extraneal
Laboratory Value Changes At Last Visit, Between Groups
Serum Alkaline Phosphatase (U/L) (130, 131 and 035 Studies)
Serum Sodium (mmol/L) All Studies
Serum Chloride (mmol/L) All Studies
Safety Profile of Extraneal
Membrane Transport Characteristics MTAC for Creatinine, Urea and Glucose
Summary of Clinical Trial Results
Extraneal Overall Summary
Proposed Indication
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