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NCT00912821
Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-center Clinical Study
Phase 4 trial testing 6 L dialysate in End-stage Renal Disease in 200 participants. Completed in 1 July 2012.
1 June 2011
Quick facts
| Lead sponsor | Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 March 2009 |
| Primary completion | 1 June 2011 |
| Estimated completion | 1 July 2012 |
| Sites | 1 location across China |
Drugs / interventions tested
- 6 L dialysate — full drug profile →
- 8 L dialysate — full drug profile →
Conditions studied
- End-stage Renal Disease — all drugs for End-stage Renal Disease →
Sponsor
Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 80, any sex, with End-stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
clinical outcome including mortality and technical failure
Time frame: 2 years
Sponsor's own description
Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment is lacking, most patients begin their PD with four 2 L exchanges per day. However, many patients have their residual renal function at the initiation of PD, an 8 L dialysate per day will enhance the toxicity of bioincompatible dialysate and increase the economic burden compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00912821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00912821 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine
- Last refreshed: 12 October 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00912821.
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