Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03812419
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2019-01-12
Brief Title:
Esomeprazole or Pantoprazole in Renal Transplantation
Sponsor:
Future University in Egypt
Organization:
Future University in Egypt
Study Overview
Official Title:
The Effect of Esomeprazole Versus Pantoprazole on Serum Cyclosporine Levels and Renal Function in Stable Kidney Transplant Recipients A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 μgL 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 recipientsCyclosporine 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 11 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 3010 the selected sample size showed an actual power of 095 α 05 and an effect size of 08 for C0 levels of CsA and an actual power of 095 α 05 and an effect size of 044 for serum creatinine levelsThe participants were randomly assigned to one of two groups by single randomization Each group received PPI therapy with a 40 mgday 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 µgL 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 mgday 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
Eighty renal transplant recipients were screened for eligibility The sample size was determined by a power calculation using G power software version 3010 the selected sample size showed an actual power of 095 α 05 and an effect size of 08 for C0 levels of CsA and an actual power of 095 α 05 and an effect size of 044 for serum creatinine levelsThe participants were randomly assigned to one of two groups by single randomization Each group received PPI therapy with a 40 mgday 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 µgL 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 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None