Influence of glucose degradation products on residual renal function in peritoneal dialysis (PD) patients

ISRCTN	ISRCTN71335154
DOI	https://doi.org/10.1186/ISRCTN71335154
Protocol serial number	4014705 (BfArM)
Sponsor	Gambro Corporate Research (Germany)
Funder	Gambro Corporate Research (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Marianne Haag-Weber
Scientific

KfH Nierenzentrum
St Elisabeth Street 23
Straubing
94315
Germany

Email	marianne.haag-weber@kfh-dialyse.de

Primary study design	Interventional
Study design	Controlled, randomised, 2 parallel groups, multicenter
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DIUREST
Study objectives	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
Ethics approval(s)	Bayerische Landesärztekammer, number 98293, 23/02/1999 (primary vote). Also approved by all other local ethics committees.
Health condition(s) or problem(s) studied	End-stage renal disease
Intervention	Conventional PD fluids with high amounts of glucose degradation products versus PD fluids with low amounts of glucose degradation products
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Peritoneal dialysis fluids
Primary outcome measure(s)	Time response of residual renal function
Key secondary outcome measure(s)	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
Completion date	31/07/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	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
Key exclusion criteria	1. Pregnancy and lactation 2. Age >80 years 3. Multiple peritonitis episodes 4. Active malignancy
Date of first enrolment	13/03/1999
Date of final enrolment	31/07/2005

KfH Nierenzentrum

Straubing
94315
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	476A	01/07/2003		No	No