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Administration of pH-Neutral Peritoneal Dialysis Solutions Containing Lactate or Bicarbonate in Children (BIOKID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claus Peter Schmitt, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01632046
First received: June 28, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage renal disease. Unfortunately progressive alterations of the peritoneal membrane occur with time on PD, leading to a continuous loss of peritoneal transport function. Recently, double-chambered PD solutions with less Glucose Degradation Products (GDPs) and neutral pH have been approved for the European market. Short term administration suggests comparable clearance rates compared with conventional solutions. In vitro studies demonstrate an improved local immune defense system. To compensate for metabolic acidosis, the available solutions either contain lactate or bicarbonate, the impact of either buffer on long term acidosis control and peritoneal membrane integrity, however, is unknown.

The prospective, European multi-center study will provide the first long term administration of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end point will be the effect of either PD-solution on peritoneal transport characteristics (D/P Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants of the peritoneal transporter status and of the continued morphological transformation of the peritoneum will be assessed.

After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution, the patients will be randomized to a 10 month study period using BicaVera and Balance, respectively. Dialysis regime and follow up in the out-patient clinic will be performed according to clinical needs (every 4 weeks); episodes of peritonitis will be treated according to international guidelines. Bicarbonate supplements will be prescribed at a dose of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5 ml of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after 3, 6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test an intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be obtained at any time of abdominal surgery. Adverse events will be screened meticulously. The trial will be carried out in accordance with the German medicines act (AMG) and other local requirements, with particular reference to the ICH guidelines for Good Clinical Practice, and the declaration of Helsinki. At study end, the patients will decide together with the responsible physician which PD-fluid should be used further one.


Condition Intervention Phase
Chronic Renal Failure
Peritoneal Membrane Disorder
Drug: lactate and bicarbonate buffered dialysis solutions
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Long-Term Administration of pH-Neutral PD Solutions Containing Lactate (BALANCE) or Bicarbonate (BICAVERA) in Children

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Evaluation of the effect of a lactate based and a bicarbonate based double-chambered, pH-neutral PD solution on peritoneal transport capacity in children. [ Time Frame: 2 months run in 10 months study period ] [ Designated as safety issue: No ]
    Following a two months run in period patients are randomized to either lactate or bicarbonate buffered PD solution. The primary outcome measure is dialysate over plasma creatinine as a measure of peritoneral transport efficacy. It will be determined at 0, 3, 6 and 10 months.


Secondary Outcome Measures:
  • Ultrafiltration [ Time Frame: 2 months run in 10 months observation ] [ Designated as safety issue: No ]
    The ultrafiltration is recorded daily by the caretakers, mean weakly ultrafiltration will be analysed. (Further outcome measures include the effect of either PD solution on acid-base balance, incidence and severity of peritonitis, and on surrogate parameters of biocompatibility and carbonyl stress).


Enrollment: 42
Study Start Date: March 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BicaVera, dialysis
Two Parallel arms. If patient randomised to the BicaVera arm he will be dialysed with bicarbonate based PD fluid (BicaVera) for 10 months. Dialysis prescription is determined according to clinical needs, dialysate glucose concentrations are 1.5, 2.3 and 4.25 %.
Drug: lactate and bicarbonate buffered dialysis solutions
Either PD-solution will be applied. Number of cycles and glucose concentration will be varied according to clinical needs. Sleep Safe system will be used and connected to Sleep Safe Cyclers in patient on CCPD.
Other Names:
  • BicaVera
  • Balance
Active Comparator: Balance, dialysis
If patient is randomised to the Balance arm, he will be dialysed with lactate based PD fluid (Balance) for 10 months. Dialysis prescription is determined according to clinical needs, dialysate glucose concentrations are 1.5, 2.3 and 4.25 %.
Drug: lactate and bicarbonate buffered dialysis solutions
Either PD-solution will be applied. Number of cycles and glucose concentration will be varied according to clinical needs. Sleep Safe system will be used and connected to Sleep Safe Cyclers in patient on CCPD.
Other Names:
  • BicaVera
  • Balance

Detailed Description:

For details please see Nau B, Schmitt CP et al; BMC Nephrol. 2004 Oct 14;5:14.

  Eligibility

Ages Eligible for Study:   1 Month to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, 1 months to 21 years of age (newborns excluded)
  • CAPD or CCPD for end stage renal disease
  • Dwell volume ~ 1100ml/m² body surface area
  • Last peritonitis at least 3 weeks ago
  • Written informed consent

Exclusion Criteria:

  • Reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adhesions
  • Uncontrolled hyperphosphatemia
  • Participation in a clinical trial with an investigational drug within one month prior start of study. Prior participation in this trial
  • Suspicion of drug abuse
  • Severe pulmonary, cardiac or hepatic disease/insufficiency
  • Any kind of malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632046

Locations
Austria
University Children's Hospital
Vienna, Austria, 1090
Finland
University Children's Hospital
Helsinki, Finland, 00029
France
University Children's Hospital
Strasbourg, France, 67098
Germany
University Children's Hospital
Essen, Germany, 45122
University Children´s Hospital
Hamburg, Germany, 20246
University Children's Hospital
Jena, Germany, 07740
Italy
University Children`s Hospital
Milan, Italy, 20122
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Claus P Schmitt, M.D. University of Heidelberg, Center for Pediatric and Adolescent Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claus Peter Schmitt, M.D., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01632046     History of Changes
Other Study ID Numbers: BIOKID 04 EU, University of Heidelberg
Study First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
peritoneal dialysis
bicarbonate/lactate buffer
peritoneal transport capacity
ultrafiltration
children

Additional relevant MeSH terms:
Kidney Failure, Chronic
Peritoneal Diseases
Renal Insufficiency
Digestive System Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Dialysis Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014