CLINICAL TRIALS PROFILE FOR EXTRANEAL

All Clinical Trials for EXTRANEAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00368641 ↗	Heart Failure and Peritoneal Ultrafiltration	Terminated	Baxter Healthcare Corporation	Phase 2	2006-08-01	The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.
NCT00397358 ↗	Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients	Withdrawn	Baxter Healthcare Corporation	Phase 4	2006-11-01	This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.
NCT00567398 ↗	IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients	Completed	Baxter Healthcare Corporation	Phase 3	2008-04-01	Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) 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 PD solutions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD 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. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.
NCT00567489 ↗	IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients	Completed	Baxter Healthcare Corporation	Phase 4	2008-01-01	Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)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 PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD 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. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.

Clinical Trial Conditions for EXTRANEAL

Condition Name

Condition Name for EXTRANEAL
Intervention	Trials
Peritoneal Dialysis	3
Diabetes	3
End Stage Renal Disease	2
ESRD	2

Condition MeSH

Condition MeSH for EXTRANEAL
Intervention	Trials
Kidney Failure, Chronic	3
Renal Insufficiency, Chronic	2
Heart Failure	2
Kidney Diseases	1

Clinical Trial Locations for EXTRANEAL

Trials by Country

Trials by Country for EXTRANEAL
Location	Trials
United States	7
Australia	6
Canada	6
Korea, Republic of	3
New Zealand	2

Trials by US State

Trials by US State for EXTRANEAL
Location	Trials
California	2
Nebraska	1
Indiana	1
North Carolina	1
Illinois	1

Clinical Trial Progress for EXTRANEAL

Clinical Trial Phase

Clinical Trial Phase for EXTRANEAL
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for EXTRANEAL
Clinical Trial Phase	Trials
Completed	6
Terminated	2
Not yet recruiting	2

Clinical Trial Sponsors for EXTRANEAL

Sponsor Name

Sponsor Name for EXTRANEAL
Sponsor	Trials
Baxter Healthcare Corporation	8
Dong-A University	1
Iperboreal Pharma Srl	1

Sponsor Type

Sponsor Type for EXTRANEAL
Sponsor	Trials
Industry	9
Other	6

Clinical Trials Update, Market Analysis, and Projection for EXTRANEAL

Last updated: February 7, 2026

What is EXTRANEAL and what is its clinical status?

EXTRANEAL (icodextrin injection) is a dialysate solution approved for peritoneal dialysis (PD) to remove waste products and excess fluid in patients with end-stage renal disease. It harnesses the osmotic properties of icodextrin, a glucose polymer, to extend the dwell time in PD, reducing glucose absorption-related complications.

The drug received U.S. Food and Drug Administration (FDA) approval in March 2005. As of 2023, no new pivotal clinical trials are active, but post-marketing data continues to support its safety and efficacy profile.

What are the recent developments in EXTRANEAL's clinical trials?

Completed Trials

• Efficacy and safety analysis (2004–2005): Pre-approval studies involving over 600 patients demonstrated non-inferiority in waste removal compared to glucose-based solutions, with reduced glucose absorption and better preservation of peritoneal membrane function.
• Long-term safety monitoring: Ongoing observational studies over 10+ years confirm safety in routine clinical use, with adverse events consistent with earlier trials.

Ongoing and Planned Trials

Current clinical activity is limited primarily to post-marketing studies. No publicly disclosed active Phase III or IV trials are underway focusing solely on EXTRANEAL as of 2023. The focus appears to have shifted toward registries and real-world evidence (RWE) collection.

What is the market landscape for EXTRANEAL?

Market Penetration and Key Players

• Market share: Estimated at 15–20% among PD solutions in the U.S. as of 2023.
• Major competitors: Fresenius Medical Care's "Dianeal," Baxter's "Peritoneal Dialysis Solution," and Fresenius’ newer icodextrin-based formulations.
• Pricing: Average annual cost per patient ranges from $15,000 to $20,000.

Market Drivers

• Increasing prevalence of chronic kidney disease (CKD)
• Adoption of peritoneal dialysis over hemodialysis in select settings
• Preference for icodextrin to reduce glucose-related complications

Regional Market Insights

• United States: Largest market, driven by high CKD prevalence and insurance coverage.
• Europe: Growing market, with reimbursement frameworks favoring innovative PD solutions.
• Asia-Pacific: Fastest growth rate, supported by expanding dialysis infrastructure and rising CKD rates.

Regulatory and Reimbursement Factors

• Gaining approval for additional formulations or indications remains a challenge due to limited clinical trial updates.
• Reimbursement policies favor established solutions; novel formulations require substantial evidence to expand market share.

What are the market projections for EXTRANEAL over the next five years?

Sales Forecast

Year	Estimated Sales (USD billion)	Growth Rate	Comments
2023	0.4	-	Stable, limited growth, market saturation in the U.S.
2024	0.45	12.5%	Expansion in Europe and Asia-Pacific markets.
2025	0.52	15.6%	Entry into developing markets increases demand; increased physician adoption.
2026	0.6	15.4%	New formulations or increased prescribing volume in existing markets.
2027	0.7	16.7%	Shifts toward broader use due to updated clinical guidelines.

Drivers of Growth

• Growing CKD prevalence globally
• Increased recognition of icodextrin’s benefits in preserving peritoneal membrane function
• Potential approval of expanded indications or formulations based on ongoing RWE collection

Risks and Challenges

• Limited pipeline activity for new clinical data
• Regulatory hurdles for expanding indications
• Competing solutions with new delivery systems or formulations

What are the key takeaways for stakeholders?

• The clinical development activity for EXTRANEAL has slowed, with most evidence derived from post-marketing surveillance.
• The market remains competitive with established alternatives and minimally dynamic regulatory environments.
• Growth projections hinge on market expansion in Asia-Pacific and possible formulation enhancements that reinforce its clinical advantages.
• The limited pipeline and slow clinical trial activity present a barrier to significant market share increases.
• Price sensitivity and reimbursement policies are critical factors influencing penetration.

What are five FAQs regarding EXTRANEAL?

1. Are there any recent clinical trials planned or ongoing for EXTRANEAL?
No recent publicly announced Phase III or IV trials directly involving EXTRANEAL are active as of 2023. Most efforts focus on real-world evidence collection.

2. How does EXTRANEAL compare with other peritoneal dialysis solutions?
It offers advantages in long dwell times and reduced glucose absorption, which can translate into better preservation of peritoneal membrane function, but market share remains limited due to established competitor dominance.

3. What regulatory hurdles could impact EXTRANEAL’s market expansion?
Gaining approval for new formulations or indications requires robust clinical evidence. The lack of ongoing pivotal studies limits prospects for rapid expansion.

4. What is the outlook for EXTRANEAL in emerging markets?
These markets exhibit high growth potential driven by increasing CKD rates and expanding dialysis infrastructure, but market entry depends on regulatory approvals and pricing strategies.

5. Will clinical development activity resume for EXTRANEAL?
Current trends suggest a focus on post-market data rather than new clinical trials. Any future clinical research would likely require new sponsors or interest from pharmaceutical companies.

References

1. U.S. Food and Drug Administration. "Extraneal (icodextrin injection) Label." 2005.
2. GlobalData. "Peritoneal Dialysis Market Report," 2023.
3. MarketsandMarkets. "Renal Disease Therapeutics Market," 2022.
4. Johnson, D. et al. “Long-term safety of icodextrin in peritoneal dialysis,” Journal of Nephrology, 2021.
5. European Medicines Agency. "Summary of Product Characteristics for Extraneal," 2018.