Clinical trial NCT00567489: IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ESRD
Diabetes
CAPD
APD
Keywords: ESRD
Diabetes
CAPD
APD
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2007-12-05
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change From the Baseline Value in HbA1c at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
Secondary outcomes:
measure: Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Number of Severe Hypoglycemic Event Requiring Medical Intervention
timeFrame: Baseline through Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
timeFrame: Baseline and Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of MRI Body Composition at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
timeFrame: Baseline, Month 6 (End of Study)
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital Chinese University of Hong Kong
state: N.t.
city: Tai Po
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
state: N.t.
city: Kowloon
country: Hong Kong
facility: Kwong Wah Hospital
city: Donggu
country: Korea, Republic of
facility: Daegu Fatima Hospital
state: Deagu
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University of Medical Center Severance Hospital
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital # 52
city: Moscow
country: Russian Federation
facility: Moscow Hospital n a S P Botkin
city: Moscow
country: Russian Federation
facility: Moscow Research n a M F Vladimirsky
city: Moscow
country: Russian Federation
facility: Moscow State Medical Institution: "Municipal Clinical Hospital #7 "
city: Samara
country: Russian Federation
facility: Samara Hospital n a M I Kalinin
city: St Petersburg
country: Russian Federation
facility: St Petersburg Mariinskaya Hospital
city: St Petersburg
country: Russian Federation
facility: St Petersburg St Elizabeth Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: Gokal R. Taking peritoneal dialysis beyond the year 2000. Perit Dial Int. 1999;19 Suppl 3:S35-42; discussion S43.
citation: 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.
citation: Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
citation: 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.
citation: 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.
citation: 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.