Kidney Transplant; ComplicationsNCT03812419
Esomeprazole or Pantoprazole in Renal Transplantation
A study testing Esomeprazole 40 mg and Pantoprazole 40mg in people with Kidney Transplant; Complications, run by Future University in Egypt.
Trial summary
prospective, parallel, open-label clinical trial was performed on forty-seven adult renal transplant recipients receiving immunosuppressive therapy with CsA doses adjusted to attain trough concentrations of 100-150 μg/L, mycophenolate mofetil (MMF) at 750 mg q12 hr and prednisolone at 5 mg daily randomized into two… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Esomeprazole 40 mg and Pantoprazole 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2016to 30 Dec 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable adult renal transplant recipients
- participants continued the same maintenance triple immunosuppressive therapy,
- triple immunosuppressive therapy was received for at least 3 years prior to the study
- transplanted 5 years before the start of the study
Who cannot join
- Paediatric patients
- patients > 65 years old
- multi-organ transplant recipients
- pregnant or lactating patients
- patients with malignancies,
- patients with active infection or inflammation
- pre-transplant GI tract disorders
About this study
Official title: The Effect of Esomeprazole Versus Pantoprazole on Serum Cyclosporine Levels and Renal Function in Stable Kidney Transplant Recipients: A Randomized Clinical Trial
prospective, parallel, open-label clinical trial was performed on forty-seven adult renal transplant recipients receiving immunosuppressive therapy with CsA doses adjusted to attain trough concentrations of 100-150 μg/L, mycophenolate mofetil (MMF) at 750 mg q12 hr and prednisolone at 5 mg daily randomized into two groups, which received esomeprazole or pantoprazole at the same dose (40 mg once daily). To compare the influence of pantoprazole and esomeprazole on serum cyclosporine (CsA) levels in stable renal transplant recipients.Cyclosporine (C0), renal function and complete blood count were measured at baseline and for 6 months. Main outcome measures Clinical signs of rejection and renal function decline, assessed by serum creatinine elevations, caused by CsA level variations in either of the study groups.
Read the detailed description
Study design and settings: This study is a prospective, single-centre, randomized, parallel, open-label 1:1 consecutive clinical trial of renal transplant recipients, with a follow-up 6 months; the study included an esomeprazole group (n = 25 at study completion) and a pantoprazole group (n = 22 at study completion). The study was conducted in the renal transplantation unit of the Nasser Institute in Cairo, Egypt.
Eighty renal transplant recipients were screened for eligibility. The sample size was determined by a power calculation using G power software version 3.0.10; the selected sample size showed an actual power of 0.95, α = 0.5 and an effect size of 0.8 for C0 levels of CsA and an actual power of 0.95, α = 0.5 and an effect size of 0.44 for serum creatinine levels.The participants were randomly assigned to one of two groups by single randomization. Each group received PPI therapy with a 40 mg/day dose of either esomeprazole (Ezogast; Copad Pharma, Cairo, Egypt) in group I (n = 25 at study completion) or pantoprazole (Pantoprazole; Pharo Pharma, Alexandria, Egypt) in group II (n = 22 at study completion).
In addition, participants continued to receive the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
Administration: CsA was administered in two divided doses adjusted to achieve a C0 of 100-150 µg/L according to the transplantation centre protocol for maintenance blood CsA levels. The morning was dose separated from PPIs by at least 15 minutes, with MMF administered at 750 mg q12 hr and prednisolone administered at 5 mg daily. Each group received 40 mg/day PPI therapy on an empty stomach, and all medications were taken orally.
Renal function tests Included Parameter Assay Kits Serum creatinine QuantiChrom creatinine assay kit Blood urea nitrogen QuantiChrom urea assay kit Serum uric acid QuantiChrom uric acid assay kit Complete blood count measurements included Parameter Assay Kits Haemoglobin White blood cells (WBCs) UniCel DxH 800 Coulter Cellular Analysis System Platelets
Whole-blood C0 values in morning samples were determined spectrophotometrically using the CEDIA Cyclosporine PLUS Assay and the Indiko Plus Benchtop Analyzer (Thermo Fisher Scientific, Waltham, MA, USA)
- Conditions
- Kidney Transplant; Complications
- Being tested
- Esomeprazole 40 mg, Pantoprazole 40mg
- Keywords
- Allograft rejection, cyclosporine, kidney transplantation, proton pump inhibitors, gastric complications.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40 mgDrug
Also called Ezogast
Esomeprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
Pantoprazole 40mgDrug
Also called Pantoprazole
Pantoprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | Esomeprazole 40 mg capsules once daily for 6 months Receives: Drug: Esomeprazole 40 mg |
| group II | Active comparator | Pantoprazole 40 mg tablets once daily for 6 months Receives: Drug: Pantoprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CsA (C0) level
trough CsA serum levels in µg/L
Measured: up to 30 weeks from date of randomization untill date of any documented change in the serum concentration
Secondary outcomes (1)
Serum creatinine
serum creatinine concentration in mg/dl
Measured: up to 30 weeks from date of randomization untill date of any documented change in the serum concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start5 Jan 2016
- Primary completion10 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University, Nasser Institute For Research and Treatment
- Responsible party
- Principal investigator, Doaa Mohamed Salah ElDin Diab ELBohy, Future University in Egypt
- Investigators
- Doaa MS ElBohy, M.Sc, Principal investigator, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812419
- Sponsor's protocol ID
- 7-2015/22
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esomeprazole Versus Pantoprazole on Serum Cyclosporine Levels and Renal Function in Stable Kidney Transplant Recipients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03812419
- Acronym / sponsor ID
- 7-2015/22
- Conditions
- Kidney Transplant; Complications
- Keywords
- Allograft rejection, cyclosporine, kidney transplantation, proton pump inhibitors, gastric complications.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Collaborators
- Ain Shams University, Nasser Institute For Research and Treatment
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 10 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 23 Jan 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.
prospective, parallel, open-label clinical trial was performed on forty-seven adult renal transplant recipients receiving immunosuppressive therapy with CsA doses adjusted to attain trough concentrations of 100-150 μg/L, mycophenolate mofetil (MMF) at 750 mg q12 hr and prednisolone at 5 mg daily randomized into two groups, which received esomeprazole or pantoprazole at the same dose (40 mg once daily). To compare the influence of pantoprazole and esomeprazole on serum cyclosporine (CsA) levels in stable renal transplant recipients.Cyclosporine (C0), renal function and complete blood count were measured at baseline and for 6 months. Main outcome measures Clinical signs of rejection and renal function decline, assessed by serum creatinine elevations, caused by CsA level variations in either of the study groups.
Detailed description
Study design and settings: This study is a prospective, single-centre, randomized, parallel, open-label 1:1 consecutive clinical trial of renal transplant recipients, with a follow-up 6 months; the study included an esomeprazole group (n = 25 at study completion) and a pantoprazole group (n = 22 at study completion). The study was conducted in the renal transplantation unit of the Nasser Institute in Cairo, Egypt.
Eighty renal transplant recipients were screened for eligibility. The sample size was determined by a power calculation using G power software version 3.0.10; the selected sample size showed an actual power of 0.95, α = 0.5 and an effect size of 0.8 for C0 levels of CsA and an actual power of 0.95, α = 0.5 and an effect size of 0.44 for serum creatinine levels.The participants were randomly assigned to one of two groups by single randomization. Each group received PPI therapy with a 40 mg/day dose of either esomeprazole (Ezogast; Copad Pharma, Cairo, Egypt) in group I (n = 25 at study completion) or pantoprazole (Pantoprazole; Pharo Pharma, Alexandria, Egypt) in group II (n = 22 at study completion).
In addition, participants continued to receive the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
Administration: CsA was administered in two divided doses adjusted to achieve a C0 of 100-150 µg/L according to the transplantation centre protocol for maintenance blood CsA levels. The morning was dose separated from PPIs by at least 15 minutes, with MMF administered at 750 mg q12 hr and prednisolone administered at 5 mg daily. Each group received 40 mg/day PPI therapy on an empty stomach, and all medications were taken orally.
Renal function tests Included Parameter Assay Kits Serum creatinine QuantiChrom creatinine assay kit Blood urea nitrogen QuantiChrom urea assay kit Serum uric acid QuantiChrom uric acid assay kit Complete blood count measurements included Parameter Assay Kits Haemoglobin White blood cells (WBCs) UniCel DxH 800 Coulter Cellular Analysis System Platelets
Whole-blood C0 values in morning samples were determined spectrophotometrically using the CEDIA Cyclosporine PLUS Assay and the Indiko Plus Benchtop Analyzer (Thermo Fisher Scientific, Waltham, MA, USA)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Drug: Esomeprazole 40 mgEsomeprazole 40 mg capsules once daily for 6 months |
| group II | Active comparator | Drug: Pantoprazole 40mgPantoprazole 40 mg tablets once daily for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stable adult renal transplant recipients
- participants continued the same maintenance triple immunosuppressive therapy,
- triple immunosuppressive therapy was received for at least 3 years prior to the study
- transplanted 5 years before the start of the study
Key exclusion criteria (7 listed)
- Paediatric patients
- patients > 65 years old
- multi-organ transplant recipients
- pregnant or lactating patients
- patients with malignancies,
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 |
|---|---|---|
| Esomeprazole 40 mgAlso: EzogastEsomeprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France). | Drug | group I |
| Pantoprazole 40mgAlso: PantoprazolePantoprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France). | Drug | group II |
Primary outcome
Serum CsA (C0) level
Time frame: up to 30 weeks from date of randomization untill date of any documented change in the serum concentration
trough CsA serum levels in µg/L
1 secondary outcome
Serum creatinine
Time frame: up to 30 weeks from date of randomization untill date of any documented change in the serum concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Doaa MS ElBohy, M.Sc principal investigator
Future University in Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Esomeprazole 40 mg and Pantoprazole 40mg in people with Kidney Transplant; Complications, run by Future University in Egypt.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 24 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum CsA (C0) level (time frame: up to 30 weeks from date of randomization untill date of any documented change in the serum concentration). 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 24 Jan 2019.