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ISRCTN
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ISRCTN71335154
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ClinicalTrials.gov identifier
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Public title
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Influence of glucose degradation products on residual renal function in peritoneal dialysis (PD) patients
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Scientific title
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Acronym
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DIUREST
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Serial number at source
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4014705 (BfArM)
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Study hypothesis
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Decline of residual renal function in PD patients is slower with the use of PD fluids with low concentration of glucose degradation products compared to standard PD fluids
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Lay summary
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Ethics approval
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Bayerische Landesärztekammer, number 98293, 23/02/1999 (primary vote). Also approved by all other local ethics committees.
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Study design
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Controlled, randomised, 2 parallel groups, multicenter
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Countries of recruitment
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Germany
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Disease/condition/study domain
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End-stage renal disease
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Participants - inclusion criteria
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1. End-stage renal disease
2. Treatment with PD
3. Age ≥18 years
4. Residual renal function ≥3 ml/min or creatinine clearance ≥6 ml/min
5. Negative serology for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
6. Written informed consent
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Participants - exclusion criteria
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1. Pregnancy and lactation
2. Age >80 years
3. Multiple peritonitis episodes
4. Active malignancy
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Anticipated start date
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13/03/1999
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Anticipated end date
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31/07/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80
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Interventions
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Conventional PD fluids with high amounts of glucose degradation products versus PD fluids with low amounts of glucose degradation products
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Primary outcome measure(s)
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Time response of residual renal function
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Secondary outcome measure(s)
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1. Peritoneal membrane transport parameters
2. CA 125 in effluent as marker for mesothelial cell mass/viability
3. Records of routine blood analyses, hospitalisation, peritonitis episodes, blood pressure
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Sources of funding
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Gambro Corporate Research (Germany)
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Trial website
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Publications
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J Am Soc Nephrol 14, 2003: 476A (poster presentation)
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Contact name
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Prof
Marianne
Haag-Weber
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Address
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KfH Nierenzentrum
St Elisabeth Street 23
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City/town
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Straubing
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Zip/Postcode
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94315
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Country
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Germany
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Email
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marianne.haag-weber@kfh-dialyse.de
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Sponsor
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Gambro Corporate Research (Germany)
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Address
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Holger-Crafoord Street 26
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City/town
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Hechingen
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Zip/Postcode
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72379
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Country
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Germany
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Email
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reinhold.deppisch@gambro.com
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Date applied
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02/03/2006
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Last edited
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14/10/2009
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Date ISRCTN assigned
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23/03/2006
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