NCT03910647

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2019

Status
unknown

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

April 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

April 3, 2019

Last Update Submit

July 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • kidney function

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

    one month

Study Arms (2)

pantoprazole with normal kidney function

EXPERIMENTAL

use pantoprazole for one month and after one month i will do for them kidney functions test

Drug: pantoprazole

pantoprazole with abnormal kidney function

EXPERIMENTAL

use pantoprazole for one month and after one month i will do for them kidney functions test

Drug: pantoprazole

Interventions

effect of this drug on renal function

Also known as: Protonix
pantoprazole with abnormal kidney functionpantoprazole with normal kidney function

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • cigarette smoker: Cigarette smoking status was defined categorically as current,former, or never smoker at baseline.
  • biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration \>\_ 126 mg/dl ,random glucose level of \>200 mg/dl.
  • patients take corticosteroid 4-patients with hypersensitivity to these drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Desbuissons G, Deray G, Mercadal L. [Proton pump inhibitors and kidney]. Nephrol Ther. 2018 Apr;14 Suppl 1:S115-S124. doi: 10.1016/j.nephro.2017.06.005. Epub 2017 Dec 20. French.

    PMID: 29274872BACKGROUND
  • Mak SK, Loo CK, Wong PN, Lo KY, Tong GM, Lam EK, Wong AK. A retrospective study on efficacy of proton-pump inhibitor-based triple therapy for eradication of Helicobacter pylori in patients with chronic renal failure. Singapore Med J. 2003 Feb;44(2):74-8.

    PMID: 14503780BACKGROUND

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • samir k abdel-hameed

    Assiut University

    STUDY DIRECTOR
  • mohammad y kobeisy, prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director .samir kamal abdel-hameed

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 10, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2020

Study Completion

October 1, 2021

Last Updated

July 17, 2019

Record last verified: 2019-07