Influence of glucose degradation products on residual renal function in peritoneal dialysis (PD) patients
| ISRCTN | ISRCTN71335154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71335154 |
| Secondary identifying numbers | 4014705 (BfArM) |
- Submission date
- 02/03/2006
- Registration date
- 23/03/2006
- Last edited
- 14/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Marianne Haag-Weber
Scientific
Scientific
KfH Nierenzentrum
St Elisabeth Street 23
Straubing
94315
Germany
| marianne.haag-weber@kfh-dialyse.de |
Study information
| Study design | Controlled, randomised, 2 parallel groups, multicenter |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Peritoneal dialysis fluids |
| Primary outcome measure | 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 study start date | 13/03/1999 |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
KfH Nierenzentrum
Straubing
94315
Germany
94315
Germany
Sponsor information
Gambro Corporate Research (Germany)
Industry
Industry
Holger-Crafoord Street 26
Hechingen
72379
Germany
| reinhold.deppisch@gambro.com | |
"ROR" |
https://ror.org/05jgtkc28 |
Funders
Funder type
Industry
Gambro Corporate Research (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 476A | 01/07/2003 | No | No |
