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Alkali Therapy for Kidney Complication
Study Summary
This trial will study whether sodium bicarbonate can improve cardiovascular and graft function in kidney transplant recipients by decreasing complement activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I regularly use supplemental oxygen.Your body mass index (BMI) is less than 40 kg/m2.I have not taken daily oral alkali like baking soda in the last 3 months.I am currently taking blood thinners.I have severe heart failure, an ejection fraction of 30% or less, or was hospitalized for heart failure recently.Your blood test results show a normal level of bicarbonate on two different days.Your kidney function, measured by eGFR, needs to be at least 45 ml/min/1.73m2.My immunosuppression treatment has been stable for at least 3 months.My high blood pressure is not under control.I am on a specific immunosuppression regimen with tacrolimus, mycophenolate mofetil, and prednisone.I am not on medications that would interfere with the trial treatments.I received a kidney transplant more than a year ago.Things that might make it hard for you to follow the study's treatments.Your blood pressure is lower than 130/80 mm Hg before the study starts.My blood pressure medication has not changed in the last month.You have very high levels of protein in your urine, which can affect test results.Your blood test shows low or high levels of potassium.You have other serious health problems that make the doctor think you might not live for more than a year.I am between 18 and 80 years old.
- Group 1: Sodium bicarbonate
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the FDA recognize Sodium bicarbonate as safe?
"The safety of sodium bicarbonate was rated a 3, as this Phase 4 trial is approved by regulatory bodies."
Could you detail the other research experiments that have used Sodium bicarbonate?
"As of now, 20 clinical trials are underway that investigate Sodium bicarbonate with one trial entering the final stage. Notably, there are 29 sites across the country conducting research on this compound with many in Decatur Georgia alone."
What medical issues is Sodium bicarbonate usually administered to address?
"Sodium bicarbonate is often used to counteract barbiturates and can also be employed for the treatment of helicobacter infections, severe diarrhea, plaque, and dental issues."
Is it possible for seniors to participate in the research trial?
"The age requirements for this trial are 18 as the lower limit and 80 as the upper boundary."
What is the maximum amount of participants for this experiment?
"Confirmed. Information found on clinicaltrials.gov reveals that this experiment, which was first announced on December 1st 2021, is actively seeking participants. Approximately 120 individuals are required from a single medical centre for the trial to proceed."
Who meets the qualifications to participate in this scientific inquiry?
"Eligibility criteria for this trial demands that potential participants have a vascular condition and are aged between 18-80. The study is searching to enrol approximately 120 individuals."
Is the enrollment period still available for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research study is still recruiting patients and has been since its initial posting on December 1st 2021. It requires at least 120 participants from one medical centre for completion."
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