Evidence map›Paper›PMID 29724188›Full record

Trial reportBMC nephrology2018

The effect of spironolactone on calcineurin inhibitor induced nephrotoxicity: a multicenter randomized, double-blind, clinical trial (the SPIREN trial).

Line Aas Mortensen, Helle C Thiesson, Birgitte Tougaard, Martin Egfjord, Anne Sophie Lind Fischer, Claus Bistrup

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01602861 (The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 14% 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.

NCT01602861 phase4completednot on this map

The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity

TypeinterventionalSponsorOdense University HospitalRan2013 to 2021Enrolled188ConditionsDisorder Related to Renal TransplantationArmsSpironolactone, placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Antihypertensive treatment for kidney transplant recipients.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. 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

6 authors at 4 institutions in 1 country.

Line Aas MortensenDepartment of Nephrology, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense C, Denmark. line.mortensen@rsyd.dk.
Helle C ThiessonDepartment of Nephrology, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense C, Denmark.
Birgitte TougaardDepartment of Nephrology, Kolding Hospital, Sygehusvej 24, 6000, Kolding, Denmark.
Martin EgfjordDepartment of Nephrology, Rigshospitalet, Blegdamsvej 9, 2100, København Ø, Denmark.
Anne Sophie Lind FischerDepartment of Nephrology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Claus BistrupDepartment of Nephrology, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense C, Denmark.
Odense University Hospital · DKAarhus University Hospital · DKKolding Hospital · DKRigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCalcineurin inhibitor induced nephrotoxicity contributes to late allograft failure in kidney transplant patients. Evidence points towards aldosterone to play a role in the development of fibrosis in multiple organs. Animal studies have indicated a beneficial effect of mineralocorticoid receptor antagonists preventing calcineurin inhibitor induced nephrotoxicity. Only few studies have explored this effect in humans. The objective of this study is to evaluate the effect of spironolactone on glomerular filtration rate and fibrosis in kidney transplant patients.

methodProspective, double-blind, randomized, clinical trial including 170 prevalent kidney transplant patients. Patients are randomized to spironolactone 25-50 mg/day or placebo for three years. Primary outcome is glomerular filtration rate evaluated by chrome-EDTA clearance. Secondary outcomes are 24-h protein excretion, amount of interstitial fibrosis in renal allograft biopsies, and cardiovascular events. As an exploratory outcome, we aim to identify markers of fibrosis in blood and urine. DISCUSSION: Long term allograft survival remains a key issue in renal transplantation, partly due to calcineurin inhibitor induced nephrotoxicity. Evidence from animal- and small human studies indicate a beneficial effect of mineralocorticoid receptor antagonism on renal function and fibrosis. This study aims to test this hypothesis in a sufficiently powered randomized clinical trial. Results might influence the future management of long term allograft survival in renal transplantation.

trial registrationClinicalTrials.gov identifier (05/17/2012): NCT01602861 . EudraCT number (05/31/2011): 2011-002243-98.

Indexed as

Calcineurin InhibitorsDouble-Blind MethodDrug Therapy, CombinationGlomerular Filtration RateGraft SurvivalHumansKidneyKidney TransplantationMineralocorticoid Receptor AntagonistsProspective StudiesSpironolactoneTreatment OutcomeCalcineurin InhibitorsMineralocorticoid Receptor AntagonistsSpironolactoneAldosteroneCyclosporine AFibrosisGlomerular filtration rateIFTAKidney transplantationMineralocorticoidTacrolimus

Identifiers

PMID29724188
PMCPMC5934785
OpenAlexW2799754238

What OpenQuestion holds

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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.