Effect of Daily Use Proton Pump Inhibitors for One Month on Kidney Function

July 15, 2019 updated by: hanan monsif israil markous, Assiut University

the Effect of Daily Use of Proton Pump Inhibitors for One Month on Renal Function

The aim of this study to: evaluate the association between prolonged use of PPI and adverse renal outcomes on patients with normal renal function and others with abnormal renal function

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Proton pump inhibitors (PPIs) are one of the most widely used classes of drugs and are prescribed primarily for gastric acid-related diseases, eradication of Helicobacter pylori, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastropathy,and gastroesophagial reflux diseases . Although PPIs have an excellent overall safety profile, some severe adverse effects, which include bone fracture, dementia, myocardial infarction, infections, micronutrient deficiencies, and kidney diseases,PPIs may trigger acute interstitial nephritis,a potentially sever adverse event commonly associated with acute kidney injury The increase in prescription and inadequate use of this class of medication calls for studies on the effects of prolonged PPI therapy on renal function.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with peptic ulcer disease or gastroesophagial reflux with normal l renal function
  • patients with peptic ulcer disease or gastroeosophagial reflux with abnormal renal function

Exclusion Criteria:

  • 1- cigarette smoker: Cigarette smoking status was defined categorically as current,former, or never smoker at baseline.

    2-biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration >_ 126 mg/dl ,random glucose level of >200 mg/dl.

    3-patients take corticosteroid 4-patients with hypersensitivity to these drugs

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: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pantoprazole with normal kidney function
use pantoprazole for one month and after one month i will do for them kidney functions test
Drug: pantoprazole
effect of this drug on renal function
Other Names:
  • Protonix
Experimental: pantoprazole with abnormal kidney function
use pantoprazole for one month and after one month i will do for them kidney functions test
Drug: pantoprazole
effect of this drug on renal function
Other Names:
  • Protonix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
kidney function
Time Frame: one month
eGFR=175xage(y/0)x^(-0.203)xplasma creatinine (mg/dl)x^(-1.154)
one month

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: samir k abdel-hameed, Assiut University
  • Study Director: mohammad y kobeisy, prof, Assiut 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 (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPIs with kidney function

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Proton Pump Inhibitor Allergy

Clinical Trials on pantoprazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe