Study of Sodium Bicarbonate in Kidney Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1 (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate levels (20 - 28 mmol/L).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients

NCT05005793

Metabolic Acidosis Kidney Transplant; Complications Vascular Diseases

RECRUITING PHASE4

Bicarbonate Administration in Kidney Transplant Recipients

NCT03428464

Kidney Transplant; Complications Metabolic Acidosis

COMPLETED NA

Preserve-Transplant Study

NCT03102996

Acidosis Renal Insufficiency Kidney Transplantation

COMPLETED PHASE4

The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients

NCT03301558

Kidney Transplant; Complications

WITHDRAWN PHASE2

Metabolic Acidosis in Renal Transplant Patients

NCT00913796

Renal Transplant Patients Metabolic Acidosis Physical Capacity +2 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Renal allograft survival ten years after transplant is only about 50%. In people with non-transplant chronic kidney disease (CKD), sodium bicarbonate treatment seems to delay progressive decline in kidney function in those with low serum bicarbonate levels (metabolic acidosis). This may be because sodium bicarbonate reduces renal ammonia production and hence fibrosis. Observational evidence suggests that people with CKD and low-normal serum bicarbonate levels might also benefit from sodium bicarbonate treatment. TGF-beta1 levels seem to be an important predictor of chronic allograft nephropathy, and alkalinizing agents may have an effect on TFG-beta1 excretion.

Retrospective analysis of participants in the African American Study of Kidney Disease and Hypertension showed the lowest risk of CKD progression was among those having baseline serum bicarbonate levels in the range of 28-30 mmol/L. Recent studies in people with pre-transplant CKD have suggested that increasing low serum bicarbonate levels (\< 22 mmol/L) with alkalinizing agents such as sodium bicarbonate and sodium citrate may reduce CKD progression.

Design: this is an open-label randomized study testing the effect of a six-month intervention with sodium bicarbonate 650 mg orally thrice daily versus no sodium bicarbonate treatment on renal ammonia excretion and urinary TGF-beta1.

Visits will occur at baseline, 3 months, and 6 months. At each follow-up visit, the study coordinator or principal investigator will review a medical questionnaire with the participant and collect a sample of blood and urine for analysis of urinary TGF-beta1, metabolic panel, pH, urinary net acid excretion, urinary bicarbonate and urinary ammonia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sodium bicarbonate

This group will receive oral sodium bicarbonate 650mg three times daily for 6 months.

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

Sodium bicarbonate 650mg by mouth three times daily for 6 months.

Control

This group will not receive any sodium bicarbonate.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium bicarbonate

Sodium bicarbonate 650mg by mouth three times daily for 6 months.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Renal transplant recipients
* Age 21-75 years
* Six months since the time of the most recent transplant
* Serum bicarbonate 20-28mM on the two most recent serum measures with the last six months
* Stable creatinine

Exclusion Criteria

* Systolic blood pressure \> 140mmHg
* Diastolic blood pressure \> 90mmHg
* Known ejection fraction \<50%
* Clinical diagnosis of heart failure
* Use of \>3 antihypertensive agents
* \> 1+ edema
* Use of alkali in the preceding 3 months
* History of noncompliance with clinic visits

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No