Esomeprazole or Pantoprazole in Renal Transplantation
Condition: Kidney Transplant; Complications
Study type: Interventional

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 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)
    

Intervention name(s): Esomeprazole 40 mg; Pantoprazole 40mg
Intervention type(s): Drug; Drug
Intervention description(s): 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 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).
Other intervention name(s): Ezogast; Pantoprazole
Intervention MeSH terms: Esomeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Allograft rejection; cyclosporine; kidney transplantation; proton pump inhibitors; gastric complications.