Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients
This study is currently recruiting participants.
Verified September 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01306149
First received: February 23, 2011
Last updated: September 28, 2011
Last verified: September 2011
| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2011 | ||||
| Last Updated Date | September 28, 2011 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins [ Time Frame: 15 years ] [ Designated as safety issue: No ] To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules, and protein bound URM in incident peritoneal dialysis (PD) patients. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01306149 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
determinants of generation rate of uremic retention solutes [ Time Frame: 15 years on average ] [ Designated as safety issue: No ] To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients. |
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| Original Secondary Outcome Measures ICMJE |
determinants of generation rate of uremic retention solutes [ Time Frame: 15 years ] [ Designated as safety issue: No ] To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients | ||||
| Official Title ICMJE | Natural History of Biochemical Parameters of Mineral Metabolism and Protein-bound Uremic Retention Molecules in Incident Peritoneal Dialysis Patients: a Longitudinal Observational Study | ||||
| Brief Summary | The aims of this study are
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: whole blood, serum, urine and dialysate |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Incident peritoneal dialysis patients |
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| Condition ICMJE | Complication of Peritoneal Dialysis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 250 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01306149 | ||||
| Other Study ID Numbers ICMJE | FWO01-03-21 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Björn Meijers, Universitaire Ziekenhuizen Leuven | ||||
| Study Sponsor ICMJE | Universitaire Ziekenhuizen Leuven | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Universitaire Ziekenhuizen Leuven | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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