Preserve-Transplant Study

Status Completed

Clinical Trial Summary

The aim of this study is to test if alkali treatment will preserve kidney graft function and diminish the progression of chronic kidney disease in renal transplant patients. Additionally the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in this cohort. This study is a multi-center, prospective, randomized, single-blind (patient), placebo-controlled interventional trial to test the superiority of alkali treatment in comparison to placebo on preservation of kidney function in 300 kidney transplant recipients. The duration of the study will be 2 years for the individual participant. The patients will be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product: Nephrotrans®) and placebo arm (placebo comparator). Several studies in CKD (chronic kidney disease) patients have shown that alkali therapy slows progression of CKD.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03102996
Study type	Interventional
Source	University of Zurich
Contact
Status	Completed
Phase	Phase 4
Start date	June 12, 2017
Completion date	July 26, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04910867` - APOL1 Genetic Testing Program for Living Donors	N/A
Completed	`NCT02723591` - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients	Phase 4
Completed	`NCT05945511` - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed	`NCT02234349` - Bile Acids and Incretins in Pancreas Kidney Transplant Patients	N/A
Completed	`NCT04496401` - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus	Phase 4
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Not yet recruiting	`NCT05934383` - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension	N/A
Withdrawn	`NCT04936971` - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response	Phase 4
Not yet recruiting	`NCT04540640` - Oxygenated Machine Preservation in Kidney Transplantation	N/A
Not yet recruiting	`NCT03090828` - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease	N/A
Recruiting	`NCT02908139` - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients	N/A
Completed	`NCT02560558` - Bela 8 Week Dosing	Phase 4
Terminated	`NCT02417870` - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation	Phase 1/Phase 2
Recruiting	`NCT02154815` - Pre-emptive Kidney Transplantation Quality of Life	N/A
Completed	`NCT02235571` - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients	N/A
Enrolling by invitation	`NCT01905514` - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients	N/A
Completed	`NCT02147210` - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1	N/A
Recruiting	`NCT01699360` - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients	Phase 4
Completed	`NCT01655563` - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation	Phase 2
Completed	`NCT01672957` - ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)	N/A