CARDIO-RENAL Advisory Committee Meeting

8/15/01


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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

Author: Eileen Deremiah