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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)
Must not have
Chronic use of supplemental oxygen
New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I regularly use supplemental oxygen.
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I have severe heart failure, an ejection fraction of 30% or less, or was hospitalized for heart failure recently.
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My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Brachial artery flow mediated dilation at 12 months
Secondary study objectives
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 more

Awards & Highlights

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.

Trial 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
1,803 Previous Clinical Trials
2,822,003 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,443 Previous Clinical Trials
4,331,007 Total Patients Enrolled
Jessica Kendrick, MD MPHPrincipal InvestigatorUniversity of Colorado Denver | Anschutz
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Sodium bicarbonate (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05005793 — Phase 4
Kidney Complication Research Study Groups: Sodium bicarbonate, Placebo
Kidney Complication Clinical Trial 2023: Sodium bicarbonate Highlights & Side Effects. Trial Name: NCT05005793 — Phase 4
Sodium bicarbonate (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05005793 — Phase 4
~45 spots leftby Aug 2026
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