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

NCT ID: NCT00567398

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non glucose sparing

Dianeal only

Group Type: ACTIVE_COMPARATOR

Dianeal

Intervention Type: DRUG

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

Glucose sparing

Physioneal, Extraneal, Nutrineal

Group Type: EXPERIMENTAL

Physioneal

Intervention Type: DRUG

Physioneal 40 or Physioneal 35

Extraneal

Intervention Type: DRUG

Extraneal - 7.5% Icodextrin

Nutrineal

Intervention Type: DRUG

Nutrineal - 1.1% Amino Acids

Interventions

Dianeal

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

Intervention Type: DRUG

Physioneal

Physioneal 40 or Physioneal 35

Intervention Type: DRUG

Extraneal

Extraneal - 7.5% Icodextrin

Intervention Type: DRUG

Nutrineal

Nutrineal - 1.1% Amino Acids

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. M/F patients 18 years of age or older

2. Diagnosis of ESRD (GFR ≤ 15 mL/min)

3. 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

4. DM (Type 1 and 2) on glycemic-control medication, for 90 days

5. HbA1c > 6.0% but ≤ 12.0%

6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

Exclusion Criteria

1. Cardiovascular event within the last 90 days

2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)

3. Allergy to starch-based polymers

4. Glycogen storage disease

5. Glycogen storage disease

6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days

7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77) at Screening.

8. Serum urea > 30 mmol/L

9. Receiving rosiglitazone maleate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

Liverpool Hospital

Sydney, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Flinders Medical Centre

Adelaide, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

St. Vincent's Hospital

Fitzroy, Victoria, Australia

Gold Coast Hospital

Southport, , Australia

Saint Boniface General Hospital

Winnipeg, Manitoba, Canada

Beausejour Hospital Corporation

Moncton, New Brunswick, Canada

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Montreal General Hospital

Montreal, Quebec, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

Auckland Hospital

Grafton, Auckland, New Zealand

Waikato DHB

Hamilton, Waikato Region, New Zealand

Countries

Australia; Canada; New Zealand

References

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

Reference Type: BACKGROUND

PMID: 10433550 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9848629 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10911641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16221697 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 1202618 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15980620 (View on PubMed)

Other Identifiers

34202

Identifier Type: -

Identifier Source: org_study_id