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

NCT00567489 | Completed Phase 4 Results

• 1 other identifier: 31998
• Study Type: interventional
• Target: 137
• Locations: 5 countries
• Sites: 19

Brief Summary

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.

Conditions

ESRD; Diabetes; CAPD; APD

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

PEN solutions: Nutrineal, Extraneal, and Physioneal

Drug: Physioneal; Drug: Extraneal; Drug: Nutrineal

Interventions

Physioneal DRUG

Physioneal 40 or Physioneal 35

glucose sparing

Dianeal DRUG

Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)

Non glucose sparing

Extraneal DRUG

7.5% Icodextrin

glucose sparing

Nutrineal DRUG

Amino Acids 1.1%

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 Dianealand/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
• Maltose, or isomaltose intolerance
• 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
• Exposure to Extraneal or Nutrineal within the last 60 days prior to Screening visit, Day 1.
• Receiving rosiglitazone maleate

Sponsors & Collaborators

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

Study Sites (19)

Prince of Wales Hospital Chinese University of Hong Kong

Shatin, N.T., Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital

Tai Po, N.T., Hong Kong

Location

Kwong Wah Hospital

Kowloon, Hong Kong

Location

Moscow Clinical Hospital # 52

Moscow, Russia

Location

Moscow Hospital n a S P Botkin

Moscow, Russia

Location

Moscow Research n a M F Vladimirsky

Moscow, Russia

Location

Moscow State Medical Institution: "Municipal Clinical Hospital #7 "

Moscow, Russia

Location

St Petersburg Mariinskaya Hospital

Saint Petersburg, Russia

Location

St Petersburg St Elizabeth Hospital

Saint Petersburg, Russia

Location

Samara Hospital n a M I Kalinin

Samara, Russia

Location

National University Hospital

Singapore, 119074, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Daegu Fatima Hospital

Donggu, Deagu, 701-600, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-717, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Yonsei University of Medical Center Severance Hospital

Seoul, 120-752, South Korea

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

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

• American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S33-50. doi: 10.2337/diacare.26.2007.s33. No abstract available.

  PMID: 12502618 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: Global CORP Clinical Trials Disclosure
• 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 4
• 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: January 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

KR (5); TW (2); HK (3); SG (2); RU (7)