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Preserve-Transplant Study

Primary Purpose

Acidosis, Renal Insufficiency, Kidney Transplantation

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Nephrotrans
Placebo
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acidosis focused on measuring Alkali, Graft, Acid base, Metabolic acidosis, Chronic kidney disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inselspital Bern, Department of Nephrology and Hypertension
  • HUG - Néphrologie
  • University Hospital Zurich, Division of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum

Placebo

Arm Description

Patients will receive Nephrotrans.

Patients will receive Placebo.

Outcomes

Primary Outcome Measures

eGFR
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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2017
Last Updated
April 21, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03102996
Brief Title
Preserve-Transplant Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acidosis, Renal Insufficiency, Kidney Transplantation
Keywords
Alkali, Graft, Acid base, Metabolic acidosis, Chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Experimental
Arm Description
Patients will receive Nephrotrans.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive Placebo.
Intervention Type
Drug
Intervention Name(s)
Nephrotrans
Intervention Description
Sodium hydrogen carbonate, ATC-Code: A02AH
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Identical capsules without active substance.
Primary Outcome Measure Information:
Title
eGFR
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilufar Mohebbi, PD Dr. med.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rudolf P Wüthrich, Prof. Dr. med.
Organizational Affiliation
University of Zurich
Official's Role
Study Director
Facility Information:
Facility Name
Inselspital Bern, Department of Nephrology and Hypertension
City
Bern
State/Province
BE
Country
Switzerland
Facility Name
HUG - Néphrologie
City
Geneva
State/Province
GE
Country
Switzerland
Facility Name
University Hospital Zurich, Division of Nephrology
City
Zurich
State/Province
ZH
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30001705
Citation
Wiegand A, Ritter A, Graf N, Arampatzis S, Sidler D, Hadaya K, Muller TF, Wagner CA, Wuthrich RP, Mohebbi N. Preservation of kidney function in kidney transplant recipients by alkali therapy (Preserve-Transplant Study): rationale and study protocol. BMC Nephrol. 2018 Jul 13;19(1):177. doi: 10.1186/s12882-018-0956-8.
Results Reference
derived

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Preserve-Transplant Study

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