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Trial record 1 of 20 for:    Preserve | Switzerland
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Preserve-Transplant Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102996
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.


Condition or disease Intervention/treatment Phase
Acidosis Renal Insufficiency Kidney Transplantation Drug: Nephrotrans Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Verum
Patients will receive Nephrotrans.
Drug: Nephrotrans
Sodium hydrogen carbonate, ATC-Code: A02AH

Placebo Comparator: Placebo
Patients will receive Placebo.
Other: Placebo
Identical capsules without active substance.




Primary Outcome Measures :
  1. eGFR [ Time Frame: 2 years ]
    Change in renal function by assessing the change in eGFR over 2 years from baseline. eGFR will be determined based on the CKD-EPI creatinine equation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent as documented by signature
  • age ≥ 18 years and able to give informed consent
  • ≥ 12 months after renal transplantation
  • stable clinical condition
  • stable graft function over the last 3 months (creatinine changes ± 15%)
  • eGFR between 15-89 ml/min/1.73 m2
  • serum bicarbonate ≤ 22 mmol/l within the last 6 months

Exclusion Criteria:

  • uncontrolled hypertension or use of > 4 antihypertensive agents
  • uncontrolled heart failure
  • serum potassium < 3.0 mmol/l
  • serum sodium > 150 mmol/l
  • use of alkali in the preceding 4 weeks
  • use of mineralocorticoid antagonists, topiramate, carbo anhydrase inhibitors or any drugs with similar effects
  • history of noncompliance with clinic visits
  • hereditary fructose intolerance
  • known hypersensitivity or allergy to the drug used in this study or to peanut, sorbitol, and soy
  • pregnancy or breastfeeding
  • intention to become pregnant during the course of the study
  • lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
  • please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  • suspected drug or alcohol abuse
  • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • enrolment of the investigator, his/her family members, employees and other dependent persons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102996


Locations
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Switzerland
Inselspital Bern, Department of Nephrology and Hypertension
Bern, BE, Switzerland
HUG - Néphrologie
Geneva, GE, Switzerland
University Hospital Zurich, Division of Nephrology
Zurich, ZH, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Nilufar Mohebbi, PD Dr. med. University of Zurich
Study Director: Rudolf P Wüthrich, Prof. Dr. med. University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03102996    
Other Study ID Numbers: Preserve-Transplant Study
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Alkali
Graft
Acid base
Metabolic acidosis
Chronic kidney disease
Additional relevant MeSH terms:
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Renal Insufficiency
Acidosis
Kidney Diseases
Urologic Diseases
Acid-Base Imbalance
Metabolic Diseases