Proton Pump Inhibitor AllergyPhase 2NCT04022837
Effect of Proton Pump Inhibitor of Daily Use for One Month on Kidney Function Test
A Phase 2 study testing Pantoprazole 40mg in people with Proton Pump Inhibitor Allergy, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Proton Pump Inhibitor Allergy
- What is being tested?
- Pantoprazole 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 3-patients take corticosteroid 4-patients with hypersensitivity to these drugs
About this study
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
Read the 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.
- Conditions
- Proton Pump Inhibitor Allergy
- Being tested
- Pantoprazole 40mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole 40mgDrug
Also called Protonix
effect of this drug on renal function
| Study group | Role | What they receive |
|---|---|---|
| pantoprazole with normal kidney function | Experimental | use pantoprazole for one month and after one month i will do for them kidney functions test Receives: Drug: Pantoprazole 40mg |
| pantoprazole with abnormal kidney function | Experimental | use pantoprazole for one month and after one month i will do for them kidney functions test Receives: Drug: Pantoprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney function
eGFR=175xage(y/0)x^(-0.203)xplasma creatinine (mg/dl)x^(-1.154)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Nov 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton Pump Inhibitor AllergyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanan monsif israil markous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022837
- Sponsor's protocol ID
- PPIs on kidney
- Status last verified
- Jul 2019
- First submitted
- 3 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proton Pump Inhibitor of Daily Use for One Month on Kidney Function Test
- ClinicalTrials.gov ID
- NCT04022837
- Acronym / sponsor ID
- PPIs on kidney
- Conditions
- Proton Pump Inhibitor Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pantoprazole with normal kidney function | Experimental | Drug: Pantoprazole 40mguse pantoprazole for one month and after one month i will do for them kidney functions test |
| pantoprazole with abnormal kidney function | Experimental | Drug: Pantoprazole 40mguse pantoprazole for one month and after one month i will do for them kidney functions test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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 3-patients take corticosteroid 4-patients with hypersensitivity to these drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazole 40mgAlso: Protonixeffect of this drug on renal function | Drug | pantoprazole with abnormal kidney function, pantoprazole with normal kidney function |
Primary outcome
kidney function
Time frame: one month
eGFR=175xage(y/0)x^(-0.203)xplasma creatinine (mg/dl)x^(-1.154)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
Related trials for Proton Pump Inhibitor Allergy
RecruitingObservational study
Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pantoprazole 40mg in people with Proton Pump Inhibitor Allergy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kidney function (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.