ESRDPhase 4ImpendiaNCT00567489
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
A Phase 4 study testing Physioneal, Dianeal and Extraneal in people with ESRD and Diabetes, run by Vantive Health LLC at 19 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Physioneal, Dianeal and Extraneal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Jan 2008to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Russia7 sites
Moscow Clinical Hospital # 52
Moscow
Moscow Hospital n a S P Botkin
Moscow
Moscow Research n a M F Vladimirsky
Moscow
Moscow State Medical Institution: "Municipal Clinical Hospital #7 "
Moscow
St Petersburg Mariinskaya Hospital
Saint Petersburg
St Petersburg St Elizabeth Hospital
Saint Petersburg
Samara Hospital n a M I Kalinin
Samara
South Korea5 sites
Kyungpook National University Hospital
Daegu, 700-721
Yeungnam University Medical Center
Daegu, 705-717
Daegu Fatima Hospital
Donggu, Deagu, 701-600
Seoul National University Hospital
Seoul, 110-744
Yonsei University of Medical Center Severance Hospital
Seoul, 120-752
Hong Kong3 sites
Kwong Wah Hospital
Kowloon
Prince of Wales Hospital Chinese University of Hong Kong
Shatin, N.T.
Alice Ho Miu Ling Nethersole Hospital
Tai Po, N.T.
Singapore2 sites
National University Hospital
Singapore, 119074
Tan Tock Seng Hospital
Singapore, 308433
Taiwan2 sites
China Medical University Hospital
Taichung, 404
National Taiwan University Hospital
Taipei, 100
About this study
Official title: Multi-Center, Prospective, Randomized Trial To Demonstrate Improved Metabolic Control of PEN VS Dianeal Only in Diabetic CAPD and APD Patients - The Impendia Trial
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.
Read the detailed description
The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
- Being tested
- Physioneal, Dianeal, Extraneal, Nutrineal
- Keywords
- ESRD, Diabetes, CAPD, APD
- Medical subject headings
- Kidney Failure, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysionealDrug
Physioneal 40 or Physioneal 35
DianealDrug
Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
ExtranealDrug
7.5% Icodextrin
NutrinealDrug
Amino Acids 1.1%
| Study group | Role | What they receive |
|---|---|---|
| Non glucose sparing | Active comparator | Dianeal only Receives: Drug: Dianeal |
| glucose sparing | Experimental | PEN solutions: Nutrineal, Extraneal, and Physioneal Receives: Drug: Physioneal; Drug: Extraneal; Drug: Nutrineal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Secondary outcomes (21)
Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Number of Severe Hypoglycemic Event Requiring Medical Intervention
Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.
Measured: Baseline through Month 6 (End of Study)
Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. 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.
Measured: 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
Values for Insulin and C-peptide are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
Values for Pro-Insulin are provided. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease.
The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished
Measured: Baseline and Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
Values for Albumin and Total Protein are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
Values for Pre-albumin are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
Values for Drained Body Weight are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
Values for BMI are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
Values for Waist Circumference are included. 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.
Measured: Baseline, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
Values for Protein and Calories are included. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6
European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. 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.
Measured: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of MRI Body Composition at Month 6
Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. 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.
Measured: Baseline, Month 6 (End of Study)
Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. 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.
Measured: Baseline, Month 6 (End of Study)
Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. 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.
Measured: Baseline, Month 6 (End of Study)
Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
Values for Left Ventricular (LV) Ejection Fraction are included. 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.
Measured: Baseline, Month 6 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567489
- Sponsor's protocol ID
- 31998
- Acronym
- Impendia
- Status last verified
- Jul 2025
- First submitted
- 4 Dec 2007
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gokal R. Taking peritoneal dialysis beyond the year 2000. Perit Dial Int. 1999;19 Suppl 3:S35-42; discussion S43.
PubMed 10433550Delarue 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.
PubMed 9848629Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
PubMed 10911641Furuya 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.
PubMed 16221697American 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.
PubMed 12502618Martikainen 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.
PubMed 15980620
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Prospective, Randomized Trial To Demonstrate Improved Metabolic Control of PEN VS Dianeal Only in Diabetic CAPD and APD Patients - The Impendia Trial
- ClinicalTrials.gov ID
- NCT00567489
- Acronym / sponsor ID
- Impendia / 31998
- Keywords
- ESRD, Diabetes, CAPD, APD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non glucose sparing | Active comparator | Drug: DianealDianeal only |
| glucose sparing | Experimental | Drug: Physioneal, Drug: Extraneal, Drug: NutrinealPEN solutions: Nutrineal, Extraneal, and Physioneal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysionealPhysioneal 40 or Physioneal 35 | Drug | glucose sparing |
| DianealDianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose) | Drug | Non glucose sparing |
| Extraneal7.5% Icodextrin | Drug | glucose sparing |
| NutrinealAmino Acids 1.1% | Drug | glucose sparing |
Primary outcome
Change From the Baseline Value in HbA1c at Month 3 and 6
Time frame: 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.
21 secondary outcomes
Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Number of Severe Hypoglycemic Event Requiring Medical Intervention
Time frame: Baseline through Month 6 (End of Study)
Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
Time frame: 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
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
Time frame: Baseline and Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
Time frame: Baseline, Month 6 (End of Study)
Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
Time frame: Baseline, Month 3, Month 6 (End of Study)
Change From Baseline of MRI Body Composition at Month 6
Time frame: Baseline, Month 6 (End of Study)
Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
Time frame: Baseline, Month 6 (End of Study)
Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
Time frame: Baseline, Month 6 (End of Study)
Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
Time frame: Baseline, Month 6 (End of Study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10433550Gokal R. Taking peritoneal dialysis beyond the year 2000. Perit Dial Int. 1999;19 Suppl 3:S35-42; discussion S43.
- Background: PubMed 9848629Delarue 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.
- Background: PubMed 10911641Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
- Background: PubMed 16221697Furuya 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.
- Background: PubMed 12502618American 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.
- Background: PubMed 15980620Martikainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physioneal, Dianeal and Extraneal in people with ESRD and Diabetes, run by Vantive Health LLC at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia, South Korea, Hong Kong, Singapore, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From the Baseline Value in HbA1c at Month 3 and 6 (time frame: Baseline, Month 3, Month 6 (End of Study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00567489, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.