Evidence map›Paper›PMID 33933012›Full record

ArticleBMC nephrology2021

Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial.

Frank H Mose, Henrik Birn, Nikolai Hoffmann-Petersen, Jesper N Bech

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC nephrology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04376216 (Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT04376216 phase4recruitingnot on this map

Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie

TypeinterventionalSponsorRegion MidtJylland DenmarkRan2017 to 2027Enrolled110ConditionsAcute Tubulo-Interstitial NephritisArmsPrednisone
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Biomarkers in acute kidney injury: On the cusp of a new era?The Journal of clinical investigation · 2023
    Article
  9. Article
  10. Article
  11. 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

4 authors at 1 institution in 1 country.

Frank H MoseUniversity Clinic in Nephrology and Hypertension, Aarhus University and Gødstrup Hospital, Herning, Denmark. frchri@rm.dk.ORCID 0000-0002-5830-5814
Henrik BirnDepartment of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark.
Nikolai Hoffmann-PetersenDepartment of Medicine, Gødstrup Hospital, Herning, Denmark.
Jesper N BechUniversity Clinic in Nephrology and Hypertension, Aarhus University and Gødstrup Hospital, Herning, Denmark.
Aarhus University · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute interstitial nephritis (AIN) is an important and common cause of acute renal failure. There are no generally accepted guidelines for the treatment of AIN, due to the lack of prospective randomized trials. Since AIN is characterized by an enhanced immune response, immunosuppressive treatment could potentially improve prognosis by attenuating inflammation and subsequent fibrosis. Despite the limited evidence of effects of steroids and potential adverse effects, prednisolone is frequently used in the treatment of AIN and there is a strong need for clinical trials on the effects of immunosuppression, including steroids, in the treatment of AIN. We aimed to evaluate the effectiveness of prednisolone treatment in AIN, and hypothesized a positive effect of prednisolone treatment on renal function in AIN.

methodsThe study is a randomized, controlled, prospective, open label multicenter study, including incident adult patients with biopsy proven AIN. Patients will be randomized 1:1 to one of 2 treatment regimens: A. No prednisolone treatment (control group) and B. B) Oral prednisolone treatment staring with 60 mg daily tapered over 8 weeks. One hundred ten patients (55 in each group) are planned to be included and followed for 1 year. Primary outcome is renal function estimated by eGFR 3 months after inclusion. Secondary outcomes are renal function after 12 months and need for renal replacement therapy and quality of life after 3 and 12 months. In addition, with-in prednisolone group analysis are performed to estimate the importance of treatment delay. Exploratory analyses include analysis of biomarkers in urine and plasma and the evaluation of these biomarkers in relation to renal prognosis and re-evaluation of renal biopsies to identify possible renal prognostic factors. DISCUSSION: Strengths and possible limitations in the design are evaluated. The study will provide important information on the effects of prednisolone treatment in AIN and as well as prognostic information relevant for future use of biomarkers and histology. Ultimately, this would lead to improved and evidence based clinical guidelines for the treatment of AIN.

trial registrationClinicalTrials.gov identifier NCT04376216 (Retrospectively registered on May 6, 2020).

Indexed as

Immunosuppressive AgentsNephritis, InterstitialPrednisoloneAcute Kidney InjuryAdministration, OralCreatinineGlomerular Filtration RateHumansMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicRemission InductionRenal Replacement TherapyCreatinineImmunosuppressive AgentsPrednisoloneAcute interstitial nephritisPrednisoloneRenal failure

Identifiers

PMID33933012
PMCPMC8088674
OpenAlexW3159743411

What OpenQuestion holds

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LicenceCC BY
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.