Evidence map›Paper›PMID 35462369›Full record

Trial reportAmerican journal of nephrology2022

Desidustat in Anemia due to Dialysis-Dependent Chronic Kidney Disease: A Phase 3 Study (DREAM-D).

Sishir Gang, Prakash Khetan, Deepak Varade, Venkata Ramakrishna Chinta, Siddharth Mavani, Umesh Gupta, S Venkata Krishna Reddy, Sunil Rajanna, Tarun Jeloka, Vivek Ruhela and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
6.7field-weighted citation impact, top 2% 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

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.

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  17. Hypoxia-inducible factor prolyl hydroxylase inhibitors for anaemia in chronic kidney disease: a clinical practice document by the European Renal Best Practice board of the European Renal Association.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Review
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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 6 institutions in 1 country.

Sishir GangMuljibhai Patel Urology Hospital, Nadiad, India.
Prakash KhetanShravan Hospital and Kidney Institute, Nagpur, India.
Deepak VaradeAsian Institute of Medical Sciences, Dombivli, India.
Venkata Ramakrishna ChintaVedanta Hospital, Guntur, India.
Siddharth MavaniMavani Dialysis and Kidney Center, Ahmedabad, India.
Umesh GuptaDepartment of Nephrology, Aakash Healthcare Super Specialty Hospital, New Delhi, India.
S Venkata Krishna ReddyVijaya Super Speciality Hospital, Nellore, India.
Sunil RajannaDepartment of Nephrology, Kempegowda Institute of Medical Sciences Hospital and Research Center, Bengaluru, India.
Tarun JelokaAditya Birla Memorial Hospital, Pimpri-Chinchwad, India.
Vivek RuhelaDepartment of Nephrology, Shri Mahant Indiresh Hospital, Dehradun, India.
Kevinkumar KansagraZydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.
Pooja KananiZydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.
Jayesh BhattZydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.
Kuldipsinh ZalaZydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.
Study Investigator Group
Cadila Healthcare (India) · INAditya Birla Memorial Hospital · INAsian Institute of Medical Sciences · INGujarat Kidney Foundation · INKempegowda Institute of Medical Sciences · INMuljibhai Patel Urological Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase 3 study to assess the efficacy and safety of the desidustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, against the epoetin alfa for the treatment of anemia in patients with chronic kidney disease (CKD) with dialysis dependency.

methodsDREAM-D was a phase 3, multicenter, open-label, randomized, active-controlled clinical study conducted across 38 centers in India. A total of 392 patients with clinical diagnosis of anemia due to CKD with dialysis need (Erythrocyte Stimulating Agent [ESA] naïve or prior ESA users) and with baseline hemoglobin levels of 8.0-11.0 g/dL (inclusive) were randomized in a 1:1 ratio to receive either desidustat oral tablets (thrice a week) or epoetin alfa subcutaneous injection for 24 weeks to maintain a hemoglobin level of 10-12 g/dL. The primary endpoint was to assess the change in the hemoglobin level between the desidustat and the epoetin alfa groups from the baseline to evaluation period week 16-24. The key secondary efficacy endpoint was the number of patients with hemoglobin response.

resultsThe least square mean (standard error) change in hemoglobin from the baseline to week 16-24 was 0.95 (0.09) g/dL in the desidustat group and 0.80 (0.09) g/dL in the epoetin alfa group (difference: 0.14 [0.14] g/dL; 95% confidence interval: -0.1304, 0.4202), which met the prespecified noninferiority margin. The number of hemoglobin responders was significantly higher in the desidustat group (106 [59.22%]) when compared to the epoetin alfa group (89 [48.37%]) (p = 0.0382). The safety profile of the desidustat oral tablet was comparable with the epoetin alfa injection. There were no new risks or no increased risks seen with the use of desidustat compared to epoetin alfa.

conclusionIn this study, desidustat was found to be noninferior to epoetin in the treatment of anemia in CKD patients on dialysis and it was well-tolerated. Clinical Trial Registry Identifier: CTRI/2019/12/022312 (India).

Indexed as

AnemiaErythropoietinHematinicsRenal Insufficiency, ChronicEpoetin AlfaHemoglobinsHumansQuinolonesRecombinant ProteinsRenal DialysisdesidustatEpoetin AlfaErythropoietinHematinicsHemoglobinsQuinolonesRecombinant ProteinsAnemiaChronic kidney diseaseDialysisHemoglobinHepcidinHypoxia-inducible factor

Identifiers

PMID35462369
PMCPMC9254304
OpenAlexW4224228384

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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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.