Evidence map›Paper›PMID 26712525›Full record

SynthesisJournal of the American Society of Nephrology : JASN2016

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

Steven G Coca, Azadeh Zabetian, Bart S Ferket, Jing Zhou, Jeffrey M Testani, Amit X Garg, Chirag R Parikh

Abstract readMeta-AnalysisReview
In one paragraph

Synthesis in Journal of the American Society of Nephrology : JASN, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
–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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Ultrafiltration for acute heart failure.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Review
  4. Acute Kidney Injury as a Safety End Point in Non-Acute Kidney Injury Clinical Trials.Journal of the American Society of Nephrology : JASN · 2026
    Article
  5. Review
  6. Article
  7. Improving Processes of Care after Acute Kidney Injury.Journal of the American Society of Nephrology : JASN · 2025
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Contrast-Associated Acute Kidney Injury.Journal of clinical medicine · 2022
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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.

Steven G CocaDivision of Nephrology, Department of Medicine and steven.coca@mssm.edu.
Azadeh ZabetianProgram of Applied Translational Research, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut; and.
Bart S FerketInstitute for Healthcare Delivery Science, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York;
Jing ZhouInstitute for Healthcare Delivery Science, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York;
Jeffrey M TestaniProgram of Applied Translational Research, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut; and.
Amit X GargDivision of Nephrology, Department of Medicine, Western University, London, Ontario, Canada.
Chirag R ParikhProgram of Applied Translational Research, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut; and.

Funding

Renal Physiology and Phenotyping CoreP30DK079310 · NIDDK · YALE UNIVERSITY · PI ARONSON, PETER S. · 2008 to 2022
$16.8M
Progression of Acute Kidney Injury to Chronic Kidney DiseaseU01DK082185 · NIDDK · YALE UNIVERSITY · PI PARIKH, CHIRAG R · 2008 to 2017
$5.1M
Novel serum and urinary biomarkers of diabetic kidney diseaseR01DK096549 · NIDDK · YALE UNIVERSITY · PI COCA, STEVEN G · 2012 to 2016
$2.9M
Long-term Prognosis of Acute Kidney Injury in Cardiac SurgeryK23DK080132 · NIDDK · YALE UNIVERSITY · PI COCA, STEVEN G · 2008 to 2012
$957k
Mentoring Program for Translational and Patient Oriented Research in AKIK24DK090203 · NIDDK · YALE UNIVERSITY · PI PARIKH, CHIRAG R · 2012 to 2016
$896k
NIDDK NIH HHS K23 DK080132NIDDK NIH HHS K24 DK090203NIDDK NIH HHS P30 DK079310NIDDK NIH HHS R01 DK096549NIDDK NIH HHS U01 DK082185
6 · The paper itself

Abstract

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials.

Indexed as

Acute Kidney InjuryCreatinineEndpoint DeterminationHumansRandomized Controlled Trials as TopicRisk AssessmentTime FactorsCreatinineacute renal failurechronic kidney diseasechronic kidney failure

Identifiers

PMID26712525
PMCPMC4978048

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.