Evidence map›Paper›PMID 26081567›Full record

Trial reportClinical and experimental nephrology2016

Rationale and study design of a randomized controlled trial to assess the effects of maintaining hemoglobin levels using darbepoetin alfa on prevention of development of end-stage kidney disease in non-diabetic CKD patients (PREDICT Trial).

Enyu Imai, Shoichi Maruyama, Masaomi Nangaku, Hideki Hirakata, Terumasa Hayashi, Ichiei Narita, Hideki Kono, Eiji Nakatani, Satoshi Morita, Yoshiharu Tsubakihara and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical and experimental nephrology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01581073 (Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 45% 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.

NCT01581073 phase3completednot on this map

Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease

TypeinterventionalSponsorTranslational Research Center for Medical Innovation, Kobe, Hyogo, JapanRan2012 to 2017Enrolled476ConditionsChronic Kidney Disease, DiabetesArmsDarbepoetin alfa
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 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

11 authors at 9 institutions in 1 country.

Enyu ImaiNakayamadera Imai Clinic, 2-8-18 Nakayamadera, Takarazuka, 665-0861, Japan. ADS12069@nifty.com.
Shoichi MaruyamaDepartment of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Masaomi NangakuDepartment of Nephrology and Endocrinology, University of Tokyo, Tokyo, Japan.
Hideki HirakataFukuoka Red Cross Hospital, Fukuoka, Japan.
Terumasa HayashiOsaka General Hospital, Osaka, Japan.
Ichiei Narita2nd Department of Medicine, Niigata University Graduate School of Medicine, Niigata, Japan.
Hideki KonoTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Eiji NakataniTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Satoshi MoritaDepartment of Biostatistics, Kyoto University, Kyoto, Japan.
Yoshiharu TsubakiharaDepartment of Nephrology, Osaka University, Suita, Japan.
Tadao AkizawaDepartment of Nephrology, Showa University, Tokyo, Japan.
Foundation for Biomedical Research and Innovation · JPJapanese Red Cross Fukuoka Hospital · JPKyoto University · JPNagoya University · JPNiigata University · JPOsaka City General Hospital · JPOsaka University · JPShowa University · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnemia associated with high mortality is a common complication of chronic kidney disease (CKD). Target hemoglobin (Hb) levels for CKD treatment remain controversial: Recent guidelines recommend a maximum of 13 g/dL to avoid increased risk of CVD. However, some smaller studies show slower progression of renal function loss with high Hb targets. Recently, darbepoetin alfa targeting Hb 11-13 g/dL was reported to improve renal composite outcome of Japanese patients compared with a low Hb group maintained at 9.0-11.0 g/dL using epoetin alfa (HR 0.66; 95% CI 0.47-0.93). The high Hb group showed significant reduction of left ventricular mass index and improved quality of life. Sub-analysis revealed greater beneficial effects in non-diabetic stage 5 CKD patients. This randomized controlled trial, PREDICT, aims to confirm the impact of targeting Hb levels of 11-13 g/dL using darbepoetin alfa with reference to a low Hb target of 9-11 g/dL.

methodsWe calculated the number of subjects (N = 440) necessary to detect a statistically significant level of α = 0.05 (two-sided) and statistical power of 80% for a minimum follow-up period of 2 years on the basis of a previous study.

resultsThe study enrolled 498 non-diabetic Japanese patients with eGFR 8-20 mL/min/1.73 m(2). The primary outcome is a composite renal endpoint (starting chronic dialysis, transplantation, eGFR 6 mL/min/1.73 m(2) or less, 50% decrease in eGFR). Average follow-up period is 2 years and the study ends in 2016.

conclusionPREDICT will determine the optimum target Hb for Japanese patients with non-diabetic CKD. (ClinicalTrials.gov No. NCT01581073).

Indexed as

AdultAgedAged, 80 and overAnemiaBiomarkersClinical ProtocolsDarbepoetin alfaDisease ProgressionFemaleGlomerular Filtration RateHematinicsHemoglobinsHumansJapanKidneyKidney Failure, ChronicBiomarkersDarbepoetin alfaHematinicsHemoglobinsCKDErythropoietin-stimulating agentESRDHemoglobin

Identifiers

PMID26081567
OpenAlexW651460001

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.