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Trial record 1 of 22 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 : Completed
First Posted : April 6, 2017
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE April 6, 2017
Last Update Posted Date April 22, 2022
Actual Study Start Date  ICMJE June 12, 2017
Actual Primary Completion Date June 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preserve-Transplant Study
Official Title  ICMJE Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Acidosis
  • Renal Insufficiency
  • Kidney Transplantation
Intervention  ICMJE
  • Drug: Nephrotrans
    Sodium hydrogen carbonate, ATC-Code: A02AH
  • Other: Placebo
    Identical capsules without active substance.
Study Arms  ICMJE
  • Experimental: Verum
    Patients will receive Nephrotrans.
    Intervention: Drug: Nephrotrans
  • Placebo Comparator: Placebo
    Patients will receive Placebo.
    Intervention: Other: Placebo
Publications * Wiegand A, Ritter A, Graf N, Arampatzis S, Sidler D, Hadaya K, Müller TF, Wagner CA, Wüthrich 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2019)
240
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
300
Actual Study Completion Date  ICMJE July 26, 2021
Actual Primary Completion Date June 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03102996
Other Study ID Numbers  ICMJE Preserve-Transplant Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Zurich
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Zurich
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nilufar Mohebbi, PD Dr. med. University of Zurich
Study Director: Rudolf P Wüthrich, Prof. Dr. med. University of Zurich
PRS Account University of Zurich
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP