Evidence map›Paper›PMID 33188693›Full record

ArticleNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2021

Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO2VATE trials.

Kai-Uwe Eckardt, Rajiv Agarwal, Youssef Mk Farag, Alan G Jardine, Zeeshan Khawaja, Mark J Koury, Wenli Luo, Kunihiro Matsushita, Peter A McCullough, Patrick Parfrey and 5 more

Open access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 8% 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.

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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Vadadustat for treatment of anemia in patients with dialysis-dependent chronic kidney disease receiving peritoneal dialysis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors and Iron Metabolism.International journal of molecular sciences · 2023
    Review
  9. Article
  10. Article
  11. Article
  12. The ASCEND-ND trial: study design and participant characteristics.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Article
  13. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Article
  14. Review
  15. Article
  16. Article
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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

15 authors at 11 institutions in 4 countries.

Kai-Uwe EckardtDepartment of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Rajiv AgarwalDepartment of Medicine Indiana University School of Medicine, Indianapolis, IN, USA.
Youssef Mk FaragAkebia Therapeutics, Inc., Cambridge, MA, USA.
Alan G JardineInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Zeeshan KhawajaAkebia Therapeutics, Inc., Cambridge, MA, USA.
Mark J KouryDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Wenli LuoAkebia Therapeutics, Inc., Cambridge, MA, USA.
Kunihiro MatsushitaDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Peter A McCulloughDepartment of Internal Medicine, Baylor University Medical Center, Dallas, TX, USA.
Patrick ParfreyDepartment of Medicine, Memorial University, St John's, Newfoundland, Canada.
Geoffrey RossAkebia Therapeutics, Inc., Cambridge, MA, USA.
Mark J SarnakDivision of Nephrology, Tufts University School of Medicine, Boston, MA, USA.
Dennis VargoAkebia Therapeutics, Inc., Cambridge, MA, USA.
Wolfgang C WinkelmayerDepartment of Medicine, Baylor College of Medicine, Houston, TX, USA.
Glenn M ChertowDepartment of Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.
Akebia Therapeutics (United States) · USBaylor College of Medicine · USBaylor University Medical Center · USCharité - Universitätsmedizin Berlin · DEIndiana University – Purdue University Indianapolis · USJohns Hopkins University · USMemorial University of Newfoundland · CAStanford University · USTufts University · USUniversity of Glasgow · GBVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundErythropoiesis-stimulating agents (ESAs) are currently the mainstay of treatment for anaemia of chronic kidney disease (CKD). Vadadustat is an investigational oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates endogenous erythropoietin formation. The INNO2VATE programme comprises two studies designed to evaluate the safety and efficacy of vadadustat versus the ESA darbepoetin alfa in ameliorating anaemia in patients with dialysis-dependent CKD (DD-CKD). Here we describe the trial design along with patient demographics and baseline characteristics.

methodsTwo Phase 3, open-label, sponsor-blind, active-controlled trials enrolled adults with anaemia of CKD who recently initiated dialysis and had limited ESA exposure (incident DD-CKD trial) or were receiving maintenance dialysis with ESA treatment (prevalent DD-CKD trial). Study periods include correction/conversion (Weeks 0-23), maintenance (Weeks 24-52), long-term treatment (Weeks 53 to end of treatment) and safety follow-up. The primary safety endpoint is the time to the first major adverse cardiovascular event and the primary efficacy endpoint is the change in haemoglobin (baseline to Weeks 24-36).

resultsA total of 369 and 3554 patients were randomized in the incident DD-CKD and prevalent DD-CKD trials, respectively. Demographics and baseline characteristics were similar among patients in both trials and comparable to those typically observed in DD-CKD.

conclusionsThe two INNO2VATE trials will provide important information on the safety and efficacy of a novel approach for anaemia management in a diverse DD-CKD population. Demographics and baseline characteristics of enrolled patients suggest that study results will be representative for a large proportion of the DD-CKD population.

Indexed as

AnemiaHematinicsRenal Insufficiency, ChronicAdultClinical Trials, Phase III as TopicErythropoietinGlycineHemoglobinsHumansPicolinic AcidsRandomized Controlled Trials as TopicRenal DialysisErythropoietinGlycineHematinicsHemoglobinsPicolinic Acidsvadadustatanaemiachronic kidney diseasedialysishypoxia-inducible factorvadadustat

Identifiers

PMID33188693
PMCPMC8577631
OpenAlexW3106260963

What OpenQuestion holds

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LicenceCC BY-NC
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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.