Ramipril in Pediatric Patients on Hemodialysis

October 10, 2020 updated by: Areej Mohamed Ateya, Ain Shams University

Impact of Angiotensin-converting Enzyme Inhibitor on Pediatric Hemodialysis Patients

The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular hemodilaysis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate the effect of Ramipril on blood pressure, heart rate, Endothelial dysfunction and inflammatory markers in pediatric patients on regular hemodilaysis and the correlation of response with ACE I/D polymorphisms.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients < 16 years old
  • Patients who have been on regular HD for 6 months or longer
  • Hypertension at enrollment

Exclusion Criteria:

  • History of active connective tissue disease
  • Acute infection within 1 month prior to the study
  • Advanced liver disease
  • Gastrointestinal dysfunction requiring parental nutrition or active malignancy
  • Use of medications such as immunosuppressive drugs within 1 month prior to the study
  • Use of anti-inflammatory medications
  • Use of vitamin E at a dose higher than 60 IU per day or vitamin C higher than 500 mg per day
  • History of myocardial infarction or cerebrovascular event within 3 months prior to the study
  • History of ACE inhibitor-associated angioedema
  • Inability to discontinue ACE inhibitors or ARBs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ramipril
Ramipril, 2.5 mg daily, administered orally for 16 weeks
Drug: Ramipril
angiotensin-converting enzyme inhibitor
Other Names:
  • Tritace
Placebo Comparator: Placebo
Placebo, matched for the interventional drug, administered orally, daily for 16 weeks
Drug: placebo
same odor, color and size as the drug but without the active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of Asymmetric dimethylarginine (ADMA)
Time Frame: 16 weeks
marker of endothelial dysfunction
16 weeks
concentration of high-sensitivity C-reactive protein (Hs-CRP )
Time Frame: 16 weeks
marker of inflammation
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ain Sh University, University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 3, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHCL 65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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