Condition category
Urological and Genital Diseases
Date applied
21/04/2004
Date assigned
24/05/2004
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Franz Schaefer

ORCID ID

Contact details

University Children's Hospital Heidelberg
Pediatric Nephrology
INF 150
Heidelberg
69120
Germany
+49-6221-5632396
Franz_Schaefer@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BIOKID

Study hypothesis

Peritoneal Dialysis (PD) is the preferred dialysis modality in children. Its major drawback is the limited technique survival due to infections and progressive ultrafiltration failure. Conventional PD solutions exert marked acute and chronic toxicity to local tissues. Prolonged exposure is associated with severe histopathological alterations including vasculopathy, neoangiogenesis, submesothelial fibrosis and a gradual loss of the mesothelial cell layer. Recently, more biocompatible PD solutions containing reduced amounts of toxic Glucose Degradation Products (GDPs) and buffered at neutral pH have been introduced into clinical practice. These solutions contain lactate, bicarbonate or a combination of both as buffer substance. Increasing evidence from clinical trials in adults and children suggests that the new PD fluids may allow for better long-term preservation of peritoneal morphology and function. However, the relative importance of the buffer in neutral-pH, low-GDP fluids is still unclear. In vitro, lactate is cytotoxic and vasoactive at the concentrations used in PD fluids. The BIOKID trial is designed to clarify the clinical significance of the buffer choice in biocompatible PD fluids.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

End stage renal disease

Intervention

Two months run-in period: standard PD solution
After randomisation: ten months treatment with pH-neutral double-chambered PD solutions containing either lactate (one group) or bicarbonate (one group)
Examinations: on clinical routine controls: blood tests, peritoneal equilibration tests, intraperitoneal pressure measurement.
If abdominal surgery is indicated: peritoneal biopsy

Intervention type

Drug

Phase

Not Specified

Drug names

Peritoneal dialysis solutions containing lactate (BALANCE) or bicarbonate (BICAVERA)

Primary outcome measures

The primary outcome measure will be the longitudinal change in 4h-D/P creatinine in the sequential PET examinations. Differential changes in this parameter will indicate differences in the development of the peritoneal solute transport status over time.

Secondary outcome measures

Secondary outcome measures will be surrogate parameters of mesothelial cell viability (CA-125), peritoneal neoangiogenesis (VEGF), fibrotic activity (TGF-beta) and local inflammation (Interleukin-6). With the same intention, the evolution of peritoneal histomorphology will be assessed in all patients available for sequential biopsies. Moreover, possible differential effects of lactate and bicarbonate buffer on the control of metabolic acidosis will be assessed by monthly blood gas analyses. Finally, the incidence and clinical course of peritonitis will be recorded as a possible indirect marker of local peritoneal macrophage function.

Overall trial start date

01/04/2003

Overall trial end date

30/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients (European multicenter trial)
1. One month to 19 years
2. Continuous ambulatory peritoneal dialysis (CAPD) or continuous cycling peritoneal dialysis (CCPD)
3. Dwell volume 1100 ml/m^2 body surface area
4. Last peritonitis at least three weeks ago
5. Written informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adhesions
2. Uncontrolled hyperphosphatemia
3. Severe pulmonary, cardiac, hepatic or systemic disease including any kind of malignancy
4. Current or recent (within 30 days) exposure to any investigational drug.

Recruitment start date

01/04/2003

Recruitment end date

30/03/2005

Locations

Countries of recruitment

Germany

Trial participating centre

University Children's Hospital Heidelberg, Pediatric Nephrology
Heidelberg
69120
Germany

Sponsor information

Organisation

Fresenius Medical Care Deutschland GmbH (Germany)

Sponsor details

Else-Kröner-Strasse 1
Bad Homburg
61352
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Fresenius Medical Care (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15485574

Publication citations

  1. Protocol

    Nau B, Schmitt CP, Almeida M, Arbeiter K, Ardissino G, Bonzel KE, Edefonti A, Fischbach M, Haluany K, Misselwitz J, Kemper MJ, Rönnholm K, Wygoda S, Schaefer F, , BIOKID: randomized controlled trial comparing bicarbonate and lactate buffer in biocompatible peritoneal dialysis solutions in children [ISRCTN81137991]., BMC Nephrol, 2004, 5, 14, doi: 10.1186/1471-2369-5-14.

Additional files

Editorial Notes