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NCT02981706
Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
NA trial testing Arteriovenous Fistula (AVF) in Chronic Kidney Disease in 20 participants. Completed in 15 February 2019.
15 February 2019
Quick facts
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 6 October 2016 |
| Primary completion | 15 February 2019 |
| Estimated completion | 15 February 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Arteriovenous Fistula (AVF)
- Arteriovenous Graft (AVG)
Conditions studied
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
- Endstage Renal Disease — all drugs for Endstage Renal Disease →
Sponsor
Columbia University
Who can join
65 and older, any sex, with Chronic Kidney Disease or Endstage Renal Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 65 years and older referred for vascular access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of functional status including gait speed, grip strength, and self-reported function over 6 months. The primary hypothesis to be tested is that AVF placement will result in a higher proportion of primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months compared to AVG placement. In addition, the study will evaluate whether AVF placement and a greater number of access procedures will result in a greater decline in functional status as measured by the average change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey.
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 NCT02981706
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Arteriovenous Fistula (AVF)
Trials testing the same drug.
- NCT03668002 — Trial of Fistula Versus Graft in Elderly Patients · NA · terminated
Other recruiting trials for Chronic Kidney Disease
Currently open trials in the same condition.
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- NCT07481526 — A Prospecitve Multicenter, Observational Registry Study · recruiting
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- NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
Other Columbia University trials
Trials by the same sponsor.
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- NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
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 NCT02981706 (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 Columbia University
- Last refreshed: 30 August 2019
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/NCT02981706.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing