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Vitamin

Nicotinamide Riboside for Kidney Disease

Phase 2

Recruiting

Led By Michel Chonchol, MD

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

CKD stage III or IV (eGFR with the 4-variable MDRD prediction equation: 20-60 mL/min/1.73m2; stable renal function in the past 3 months)

Weight stable in the prior 3 months (<2 kg weight change) and willing to remain weight stable throughout the study

Must not have

Woman who are pregnant, nursing or planning to become pregnant

Patients with advanced CKD requiring chronic dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Summary

This trial will test whether nicotinamide riboside, a precursor of NAD+, is safe and effective in reducing aortic stiffness and blood pressure in patients with stage III and IV CKD.

Who is the study for?

This trial is for adults aged 35-80 with moderate to severe chronic kidney disease (stages III or IV), who have had stable weight and blood pressure control. They must not be pregnant, planning pregnancy, or nursing, and should not have been hospitalized recently or taking certain immunosuppressants.

What is being tested?

The trial tests if nicotinamide riboside supplements can reduce arterial stiffness and high systolic blood pressure in CKD patients. It's a phase IIa study where participants are randomly given either the supplement or a placebo twice daily for three months.

What are the potential side effects?

Potential side effects of nicotinamide riboside may include nausea, fatigue, headaches, diarrhea, indigestion and other gastrointestinal discomforts. The safety profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is moderately to severely reduced but stable.

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My weight has been stable, with less than a 2 kg change, for the last 3 months.

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I am between 35 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 am pregnant, nursing, or planning to become pregnant.

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I am on chronic dialysis for advanced kidney disease.

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I have not taken immunosuppressants like cyclosporine or steroids in the past year.

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I have a history of severe heart failure.

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I have been hospitalized within the last month.

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My doctor thinks I have less than a year to live due to other health issues.

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I have been diagnosed with cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 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

carotid-femoral pulse wave velocity

Secondary study objectives

Systolic blood pressure

Other study objectives

Change in blood cellular NAD+ metabolism

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v4.0

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotinamide RibosideExperimental Treatment1 Intervention

Each nicotinamide riboside capsule contains 250 mg of nicotinamide riboside chloride mixed with microcrystalline cellulose. Dosage: 500 mg by mouth twice a day for 3 months.

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo capsules.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide riboside

2021

Completed Phase 3

~390

0 / 10Eligibility criteria met