NCT03007537

The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

Terminated NA Results posted Last updated 26 January 2023

What this trial tests

NA trial testing Erythropoietin in Acute Kidney Injury in 101 participants. Terminated before completion.

Timeline

1 October 2015

Primary endpoint
28 December 2018

28 December 2018

Quick facts

Lead sponsor	Nanjing First Hospital, Nanjing Medical University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	101
Start date	1 October 2015
Primary completion	28 December 2018
Estimated completion	28 December 2018
Sites	1 location across China

Drugs / interventions tested

• Erythropoietin — full drug profile →
• 0.9% sodium chloride
• cardiac surgery

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →
• Cardiac Disease — all drugs for Cardiac Disease →
• Surgery — all drugs for Surgery →

Sponsor

Nanjing First Hospital, Nanjing Medical University

Who can join

Adults 18 to 80, any sex, with Acute Kidney Injury or Cardiac Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Acute Kidney Injury Primary · 7 days

Occurrence of acute kidney injury according to KDIGO guideline

Group	Value	95% CI
Control Group	15
Erythropoietin Group	9

Number of Participants With Renal Replacement Therapy Secondary · 3 months

suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours.

Group	Value	95% CI
Control Group	0
Erythropoietin Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Group

Serious: 10/46 (22%)

Deaths: 0/46

Erythropoietin Group

Serious: 9/46 (20%)

Deaths: 0/46

Serious adverse events (2 terms)

Reaction	System	Control Group	Erythropoietin Group
pulmonary infection	Infections and infestations	—	—
Thrombotic events	Vascular disorders	—	—

Most-reported serious reactions: pulmonary infection, Thrombotic events.

Data from ClinicalTrials.gov NCT03007537 adverse events section.

Sponsor's own description

To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney injury, and trying to provide evidence for protecting the renal function and improving the prognosis for patients after cardiac surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Perioperative Acute Kidney Injury.
   Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968