NCT03391830

Brief Summary

To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 12, 2021

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

December 30, 2017

Last Update Submit

January 8, 2021

Conditions

Contrast-induced NephropathyStatinAscorbic AcidAKI

Outcome Measures

Primary Outcomes (1)

  • Contrast Induced-Acute Kidney Injury

    Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure.

    3 days

Secondary Outcomes (1)

  • long-term Renal function by estimated GFR

    30 days

Study Arms (2)

Atorvastatin-Ascorbic acid

ACTIVE COMPARATOR

atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg

Drug: Atorvastatin-Ascorbic acid

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Atorvastatin-Ascorbic acidDRUG

atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg

Atorvastatin-Ascorbic acid
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned computed tomography urogram (CTU)
  • Statin naive, or not on statin treatment for at least 14 day

You may not qualify if:

  • History of liver disease or elevated serum transaminases
  • History of rhabdomyolysis or elevated creatinine kinase
  • History of iodinated CM use within 14 days before randomization
  • History of N-acetylcysteine, metformin or nonsteroidal anti-inflammatory drugs use within 48 hours of the procedure.
  • History of hypersensitivity reaction to contrast media
  • Pregnancy or lactation
  • Acute renal failure
  • End-stage renal disease requiring dialysis
  • Cardiogenic shock or pulmonary edema
  • Multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

Study Officials

  • Yasser Othman, MD

    Urology and nephrology center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Uro-oncology Fellow - Urology and Nephrology Center - Mansoura

Study Record Dates

First Submitted

December 30, 2017

First Posted

January 5, 2018

Study Start

January 15, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 12, 2021

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)