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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR EXTRANEAL

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Clinical Trials for Extraneal

Trial ID Title Status Sponsor Phase Summary
NCT00397358 Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients Terminated Baxter Healthcare Corporation Phase 4 This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.
NCT00725517 Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange Completed Shanghai Jiao Tong University School of Medicine Phase 4 The purpose of this study is to evaluate the efficacy and safety of a 7.5% Icodextrin peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) in Chinese uremic patients.Patients were divided into Dianeal group or Extraneal group for long dwell time. Net ultrafiltration, small solute clearance and relationship between different transport group were used to evaluate efficacy of Icodextrin. Physical examination, vital signs and laboratory tests were used to evaluate safety of Icodextrin.
NCT01124227 Peritoneal Dialysis in Congestive Heart Failure Unknown status Baxter Healthcare Corporation Phase 3 Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme. Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy.. Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years). Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®). Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).
NCT01124227 Peritoneal Dialysis in Congestive Heart Failure Unknown status Roche BV Netherlands Phase 3 Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme. Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy.. Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years). Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®). Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).
NCT01124227 Peritoneal Dialysis in Congestive Heart Failure Unknown status Martini Hospital Groningen Phase 3 Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme. Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy.. Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years). Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®). Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).
NCT01219959 Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients Completed Baxter Healthcare Corporation Phase 3 Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Extraneal

Condition Name

Condition Name for Extraneal
Intervention Trials
Peritoneal Dialysis 2
Renal Insufficiency 1
Chronic Kidney Disease 1
CAPD 1
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Condition MeSH

Condition MeSH for Extraneal
Intervention Trials
Kidney Failure, Chronic 2
Renal Insufficiency, Chronic 2
Heart Failure 1
Kidney Diseases 1
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Clinical Trial Locations for Extraneal

Trials by Country

Trials by Country for Extraneal
Location Trials
United States 3
Colombia 1
Netherlands 1
Korea, Republic of 1
Belgium 1
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Trials by US State

Trials by US State for Extraneal
Location Trials
Nebraska 1
Indiana 1
California 1
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Clinical Trial Progress for Extraneal

Clinical Trial Phase

Clinical Trial Phase for Extraneal
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for Extraneal
Clinical Trial Phase Trials
Completed 2
Recruiting 2
Unknown status 1
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Clinical Trial Sponsors for Extraneal

Sponsor Name

Sponsor Name for Extraneal
Sponsor Trials
Baxter Healthcare Corporation 4
Pr Eric Goffin 1
Martini Hospital Groningen 1
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Sponsor Type

Sponsor Type for Extraneal
Sponsor Trials
Other 5
Industry 4
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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
McKinsey
Moodys
Fuji
Accenture
Julphar
Merck
Farmers Insurance

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