Evidence map›Paper›PMID 25233856›Full record

Trial reportBMC nephrology2014

A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design.

Hidetomo Nakamoto, Toshiro Fujita, Hideki Origasa, Masanao Isono, Hajimu Kurumatani, Kiyonobu Okada, Hiroyuki Kanoh, Takashi Kiriyama, Shunsuke Yamada

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC nephrology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01090037 (TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure), 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 41% 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.

NCT01090037 phase2 / phase3completednot on this map

TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

TypeinterventionalSponsorToray Industries, IncRan2010 to 2015Enrolled892ConditionsChronic Renal Failure, Glomerular Disease, NephrosclerosisArmsTRK-100STP high dose, TRK-100STP low dose, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Antiplatelet agents for chronic kidney disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Prostacyclin analog beraprost sodium efficacy in primary glomerular disease or nephrosclerosis: Analysis of the Japanese subgroup in CASSIOPEIR study.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2021
    Trial
  3. Trial
  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

9 authors at 6 institutions in 1 country.

Hidetomo NakamotoDepartment of General Internal Medicine, Saitama Medical University, 38 Morohongo, Moroyamamachi, Iruma-gun, Saitama 350-0495, Japan. nakamo_h@saitama-med.ac.jp.
Toshiro Fujita
Hideki Origasa
Masanao Isono
Hajimu Kurumatani
Kiyonobu Okada
Hiroyuki Kanoh
Takashi Kiriyama
Shunsuke Yamada
Astellas Pharma (Japan) · JPNihon University · JPSaitama Medical University · JPThe University of Tokyo · JPToray Industries, Inc. (Japan) · JPUniversity of Toyama · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic kidney disease (CKD) is public health concern even in Asian countries. TRK-100STP, a sustained release tablet of an orally-active prostacyclin analogue, beraprost sodium, is suggested to suppress worsening of some parameters of renal filtration function, containing in slope of 1/serum creatinine (1/SCr) vs. time in a phase II clinical trial. METHODS/

designWe describe the design of the phase IIb/III trial of TRK-100STP, CASSIOPEIR (CRF Asian Study with Oral PGI2 derivative for Evaluating Improvement of Renal function) conducted in approximately 160 centers in China, Hong Kong, Japan, Malaysia, Republic of Korea, Taiwan, and Thailand. A total of 750 patients (n = 250 per group) with primary glomerular disease or nephrosclerosis were planned to be enrolled. Patients were randomized into one of three treatment groups in a double-bind, placebo-controlled manner: TRK-100STP 60 μg b.i.d.; TRK-100STP 120 μg b.i.d.; or placebo. The treatment period is planned to last 2 to 4 years. The primary efficacy endpoint is the renal composite endpoint including doubling of SCr and ESRD (dialysis induction, renal transplantation, or increase in SCr to ≥ 6.0 mg/dL). DISCUSSION: This trial targeting CKD patients is designed to (a) demonstrate the superiority of TRK-100STP over placebo using renal composite endpoints, (b) determine the recommended clinical dose, and (c) assess the safety of TRK-100STP in this population and setting.

trial registrationClinicalTrials.gov Identifier: NCT01090037.

Indexed as

Administration, OralAdultAgedDouble-Blind MethodEpoprostenolFemaleFollow-Up StudiesHumansInternationalityKidney GlomerulusMaleMiddle AgedNephrosclerosisYoung AdultberaprostEpoprostenol

Identifiers

PMID25233856
PMCPMC4181382
OpenAlexW2085366166

What OpenQuestion holds

Textmetadata
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.