Clincosm LogoSign in Get a demo

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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03910647
Collaborator
(none)
200
Enrollment
2
Arms
22
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
the Effect of Daily Use of Proton Pump Inhibitors for One Month on Renal Function
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. kidney function [one month]

      eGFR=175xage(y/0)x^(-0.203)xplasma creatinine (mg/dl)x^(-1.154)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    hanan monsif israil markous, director .samir kamal abdel-hameed, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03910647
    Other Study ID Numbers:
    • PPIs with kidney function
    First Posted:
    Apr 10, 2019
    Last Update Posted:
    Jul 17, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pantoprazole

    Study Results

    No Results Posted as of Jul 17, 2019