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Alkylating agents
Alkali Therapy for Kidney Complication
Phase 4
Recruiting
Led By Jessica Kendrick, MD MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable immunosuppression regimen for at least three months prior to randomization
Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
Study Summary
This trial will study whether sodium bicarbonate can improve cardiovascular and graft function in kidney transplant recipients by decreasing complement activation.
Who is the study for?
This trial is for kidney transplant recipients aged 18-80 with stable health, not on conflicting meds or treatments, and a BMI under 40. They should have had their transplant at least a year ago, be on specific immunosuppressants, and have certain levels of serum bicarbonate and eGFR—a measure of kidney function.Check my eligibility
What is being tested?
The study tests if sodium bicarbonate can improve heart and graft health in those who've received a kidney transplant. It's a double-blind study where half the participants will get sodium bicarbonate and the other half a placebo for one year to compare effects.See study design
What are the potential side effects?
While the trial description doesn't list side effects directly, sodium bicarbonate may cause stomach pain, nausea, swelling due to fluid buildup (edema), high blood pressure or alkalosis (when body fluids contain too much base).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My immunosuppression treatment has been stable for at least 3 months.
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I am not on medications that would interfere with the trial treatments.
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I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brachial artery flow mediated dilation at 12 months
Secondary outcome measures
Change in Large elastic artery stiffness and compliance at 12 months
Change in Tubular atrophy at 12 months
Change in interstitial fibrosis at 12 months
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium bicarbonateExperimental Treatment1 Intervention
Oral sodium bicarbonate at a dose of 0.5 mEq/kg-lean body weight/day
Group II: PlaceboPlacebo Group1 Intervention
Oral placebo at a dose of 0.5 mEq/kg-lean body weight/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium bicarbonate
2012
Completed Phase 4
~3680
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,755 Previous Clinical Trials
2,166,299 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,379 Previous Clinical Trials
4,315,378 Total Patients Enrolled
Jessica Kendrick, MD MPHPrincipal InvestigatorUniversity of Colorado Denver | Anschutz
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Sodium bicarbonate
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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