IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients

NCT00567398 | Completed Phase 3 Results

• 1 other identifier: 34202
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 16

Brief Summary

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.

Conditions

ESRD; Diabetes

Keywords

ESRD; Diabetes; CAPD; APD

Outcome Measures

Primary Outcomes (1)

• Change From the Baseline Value in HbA1c at Month 3 and 6

  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.

  Baseline, Month 3, Month 6 (End of Study)

Secondary Outcomes (21)

• 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)

• Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6

  Baseline, Month 3, Month 6 (End of Study)

• Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6

  Baseline, Month 3, Month 6 (End of Study)

Study Arms (2)

non glucose sparing

ACTIVE COMPARATOR

Dianeal only

Drug: Dianeal

Glucose sparing

EXPERIMENTAL

Physioneal, Extraneal, Nutrineal

Drug: Physioneal; Drug: Extraneal; Drug: Nutrineal

Interventions

Dianeal DRUG

Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)

non glucose sparing

Physioneal DRUG

Physioneal 40 or Physioneal 35

Glucose sparing

Extraneal DRUG

Extraneal - 7.5% Icodextrin

Glucose sparing

Nutrineal DRUG

Nutrineal - 1.1% Amino Acids

Glucose sparing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• M/F patients 18 years of age or older
• Diagnosis of ESRD (GFR ≤ 15 mL/min)
• CAPD or APD using only Dianeal and/or Physioneal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
• DM (Type 1 and 2) on glycemic-control medication, for 90 days
• HbA1c \> 6.0% but ≤ 12.0%
• Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

You may not qualify if:

• Cardiovascular event within the last 90 days
• Ongoing clinically significant congestive heart failure (NYHA class III or IV)
• Allergy to starch-based polymers
• Glycogen storage disease
• Glycogen storage disease
• Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
• Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77) at Screening.
• Serum urea \> 30 mmol/L
• Receiving rosiglitazone maleate

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (16)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Gold Coast Hospital

Southport, 4215, Australia

Location

Saint Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Beausejour Hospital Corporation

Moncton, New Brunswick, E1A1J9, Canada

Location

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

Auckland Hospital

Grafton, Auckland, New Zealand

Location

Waikato DHB

Hamilton, Waikato Region, New Zealand

Location

Related Publications (6)

• Gokal R. Taking peritoneal dialysis beyond the year 2000. Perit Dial Int. 1999;19 Suppl 3:S35-42; discussion S43.

  PMID: 10433550 BACKGROUND

• Delarue J, Maingourd C, Couet C, Vidal S, Bagros P, Lamisse F. Effects of oral glucose on intermediary metabolism in continuous ambulatory peritoneal dialysis patients versus healthy subjects. Perit Dial Int. 1998 Sep-Oct;18(5):505-11.

  PMID: 9848629 BACKGROUND

• Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.

  PMID: 10911641 BACKGROUND

• Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. doi: 10.1093/ndt/gfi197. Epub 2005 Oct 12.

  PMID: 16221697 BACKGROUND

• Nundy S, Baron JH. The use of neutral red as a peroperative test of vagal innervation. Scand J Gastroenterol. 1975;10(8):847-50.

  PMID: 1202618 BACKGROUND

• Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. doi: 10.1159/000086553. Epub 2005 Jun 23.

  PMID: 15980620 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Diabetes Mellitus

Interventions

Icodextrin; Nutrineal

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Limitations and Caveats

This is a pooled analysis of NCT00567489, NCT00567398, and NCT01219959. Given that the glucose content of the PD solutions were similar, the pooling of the results were considered a valid method to answer the underlying research questions.

Results Point of Contact

• Title: Clinical Trials Disclosure Group
• Organization: Vantive

Global.CORP.ClinicalTrialsDisclosure@vantive.com

+1 2249484283

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: April 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 22, 2025
• Results First Posted: June 3, 2019

Record last verified: 2025-07

Locations

CA (5); AU (9); NZ (2)