Condition category
Urological and Genital Diseases
Date applied
02/03/2006
Date assigned
23/03/2006
Last edited
14/10/2009
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 Marianne Haag-Weber

ORCID ID

Contact details

KfH Nierenzentrum
St Elisabeth Street 23
Straubing
94315
Germany
marianne.haag-weber@kfh-dialyse.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4014705 (BfArM)

Study information

Scientific title

Acronym

DIUREST

Study hypothesis

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

Bayerische Landesärztekammer, number 98293, 23/02/1999 (primary vote). Also approved by all other local ethics committees.

Study design

Controlled, randomised, 2 parallel groups, multicenter

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Peritoneal dialysis fluids

Primary outcome measures

Time response of residual renal function

Secondary outcome measures

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

Overall trial start date

13/03/1999

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Pregnancy and lactation
2. Age >80 years
3. Multiple peritonitis episodes
4. Active malignancy

Recruitment start date

13/03/1999

Recruitment end date

31/07/2005

Locations

Countries of recruitment

Germany

Trial participating centre

KfH Nierenzentrum
Straubing
94315
Germany

Sponsor information

Organisation

Gambro Corporate Research (Germany)

Sponsor details

Holger-Crafoord Street 26
Hechingen
72379
Germany
reinhold.deppisch@gambro.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Gambro Corporate Research (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

J Am Soc Nephrol 14, 2003: 476A (poster presentation)

Publication citations

Additional files

Editorial Notes