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Dianeal

Phase 3

End Stage Renal Disease (ESRD) | Small molecule | Metabolic |Baxter International Inc.|Last Updated: Jul 24, 2025

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical trial landscape

Dianeal · 2 trials · 4 indications

Phase 3 2
NCT01219959Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) PatientsEnd Stage Renal Disease (ESRD)
COMPLETED71 Analytics
NCT00567398IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD PatientsESRD
COMPLETED43 Analytics
PHASE3COMPLETED
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
End Stage Renal Disease (ESRD)
NCT0121995971
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PHASE3COMPLETED
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
ESRD
NCT0056739843
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Study Endpoints
Primary Endpoints
Change From the Baseline Value in HbA1c at Month 3 and 6
Baseline, Month 3, Month 6 (End of Study)

HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Secondary Endpoints
Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
Baseline, Month 3, Month 6 (End of Study)
Number of Severe Hypoglycemic Event Requiring Medical Intervention
Baseline through Month 6 (End of Study)
Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
Baseline, Month 3, Month 6 (End of Study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Non-glucose SparingACTIVE_COMPARATORDianeal only
Glucose SparingEXPERIMENTALDianeal, Extraneal, Nutrineal
non glucose sparingACTIVE_COMPARATORDianeal only
Interventions
NameTypeDescription
DianealDRUGDianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose
Dianeal, Extraneal, NutrinealDRUGDianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin
PhysionealDRUGPhysioneal 40 or Physioneal 35
ExtranealDRUGExtraneal - 7.5% Icodextrin
NutrinealDRUGNutrineal - 1.1% Amino Acids
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Male or Female patients 18 years of age or older 2. Diagnosis of ESRD \[Glomerular Filtration Rate (GFR) ≤ 15 mL/min\] 3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time 4. Diabetes Mellitus (Type 1 and 2) 5. HbA1c \> 6.0% bu...

Countries:ColombiaAustraliaCanadaNew Zealand
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