Evidence map›Paper›PMID 23756769›Full record

Trial reportTransplantation2013

A rapid noninvasive assay for the detection of renal transplant injury.

Tara K Sigdel, Matthew J Vitalone, Tim Q Tran, Hong Dai, Szu-Chuan Hsieh, Oscar Salvatierra, Minnie M Sarwal

3 registry-linked trialsAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Transplantation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02424227 unknown statusnot on this mapstarted 2015, after this paper: background citation

Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients

TypeobservationalSponsorCareDxRan2015 to 2019Enrolled401ConditionsKidney Transplant Recipients
NCT04166149 completednot on this mapstarted 2019, after this paper: background citation

Non-invasive Blood Test to Diagnose Acute Rejection After Pancreas and Kidney Transplantation: Pancreas and Renal Rejection Diagnosis Using Circulating Donor-derived Cell-free DNA in Peripheral Blood

TypeobservationalSponsorUniversity of Maryland, BaltimoreRan2019 to 2024Enrolled140ConditionsTransplant, Failure,Kidney, Transplant, Failure, PancreasArmsdd-cfDNA Blood Test
NCT04855422 completednot on this mapstarted 2021, after this paper: background citation

Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.

TypeobservationalSponsorMontefiore Medical CenterRan2021 to 2026Enrolled41ConditionsTransplant, Complication, RejectionArmsAllosure, AlloMap
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 134 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Article

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Tara K SigdelCalifornia Pacific Medical Center Research Institute, San Francisco, CA 94107, USA
Matthew J Vitalone
Tim Q Tran
Hong Dai
Szu-Chuan Hsieh
Oscar Salvatierra
Minnie M Sarwal
California Pacific Medical Center · USPalo Alto University · US

Funding

Defining Biomarkers in Pediatric Renal TransplantationR01AI061739 · NIAID · STANFORD UNIVERSITY · PI SARWAL, MINNIE M · 2004 to 2007
$1.6M
NIAID NIH HHS R01 AI061739
6 · The paper itself

Abstract

backgroundThe copy number of donor-derived cell-free DNA (dd-cfDNA) in blood correlates with acute rejection (AR) in heart transplantation. We analyzed urinary dd-cfDNA as a surrogate marker of kidney transplant injury.

methodsSixty-three biopsy-matched urine samples (41 stable and 22 allograft injury) were analyzed from female recipients of male donors for chromosome Y (donor)-specific dd-cfDNA. All biopsies were semiquantitatively scored by a single pathologist. Standard statistical measures of correlation and significance were used.

resultsThere was baseline scatter for urinary dd-cfDNA/μg urine creatinine across different patients, even at the time of stable graft (STA) function (undetected to 12.26 copies). The mean urinary dd-cfDNA in AR (20.5 ± 13.9) was significantly greater compared with STA (2.4 ± 3.3; P<0.0001) or those with chronic allograft injury (CAI; 2.4 ± 2.4; P=0.001) but no different from BK virus nephropathy (BKVN; 20.3±15.7; P=0.98). In AR and BKVN, the intrapatient drift was highly significant versus STA or CAI patients (10.3 ± 7.4 in AR; 12.3 ± 8.4 in BKVN vs. -0.5 ± 3.5 in STA and 2.3 ± 2.6 in CAI; P<0.05). Urinary dd-cfDNA correlated with protein/creatinine ratio (r=0.48; P<0.014) and calculated glomerular filtration rate (r=-0.52; P<0.007) but was most sensitive for acute allograft injury (area under the curve=0.80; P<0.0006; 95% confidence interval, 0.67-0.93).

conclusionUrinary dd-cfDNA after renal transplantation has patient specific thresholds, reflecting the apoptotic injury load of the donor organ. Serial monitoring of urinary dd-cfDNA can be a surrogate sensitive biomarker of acute injury in the donor organ but lacks the specificity to distinguish between AR and BKVN injury.

Indexed as

Chromosomes, Human, YAcute DiseaseAdolescentAdultApoptosisBiomarkersBK VirusChildDNADNA Copy Number VariationsFemaleGraft RejectionHumansImmunosuppressive AgentsKidney TransplantationMaleBiomarkersDNAImmunosuppressive Agents

Identifiers

PMID23756769
PMCPMC4472435
OpenAlexW1978071839

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.