Evidence map›Paper›PMID 35112455›Full record

Trial reportDiabetes, obesity & metabolism2022

Impact of random variation in albuminuria and estimated glomerular filtration rate on patient enrolment and duration of clinical trials in nephrology.

Simke W Waijer, Michele Provenzano, Skander Mulder, Peter Rossing, Frederik Persson, Vlado Perkovic, Hiddo J L Heerspink

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
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.

Simke W WaijerDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.ORCID 0000-0003-1717-0463
Michele ProvenzanoSecond University of Naples, Naples, Italy.
Skander MulderDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Peter RossingSteno Diabetes Centre Copenhagen, Gentofte, Denmark.
Frederik PerssonSteno Diabetes Centre Copenhagen, Gentofte, Denmark.
Vlado PerkovicGeorge Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.ORCID 0000-0002-3126-3730

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo test whether a screening approach with more flexible urinary albumin creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) thresholds would decrease screen failure rate without negatively impacting on the event rate and overall study duration.

methodsWe performed a post-hoc analysis of the ALTITUDE trial. We selected participants randomized to placebo with a UACR of >300 mg/g and an eGFR between 30 mL/min/1.73 m

resultsThe base scenario consisted of 848 participants (median UACR 1239 mg/g; median eGFR 44 mL/min/1.73 m

conclusionMore flexible albuminuria and eGFR-based inclusion criteria, in participants who met the inclusion criteria of a trial based on pre-screening values prior to the clinical trial, decreases screen failure rates and accelerated patient enrolment leading to more efficient trial conduct without impacting the overall trial duration.

Indexed as

Diabetes Mellitus, Type 2NephrologyAlbuminuriaCreatinineFemaleGlomerular Filtration RateHumansKidney Function TestsMaleCreatininealbuminuriachronic kidney diseaseclinical trial designeGFRscreen failure

Identifiers

PMID35112455
PMCPMC9306498

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.