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Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease

NCT ID: NCT02140814

Last Updated: 2016-12-01

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Brief Summary

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The goal of this pilot study is to evaluate the feasibility of administering niacinamide to patients with autosomal dominant polycystic kidney disease, to develop methods to assess the biological efficacy of niacinamide, and to perform a preliminary exploration of its clinical effect on kidney cyst growth and kidney function.

Detailed Description

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Niacinamide is a form of vitamin B3. Vitamin B3 is found in many foods including yeast, meat, fish, milk, eggs, green vegetables, beans, and cereal grains. Recent studies in mice have shown that niacinamide, at high doses, may slow kidney cyst growth from polycystic kidney disease (PKD).

By doing this study, the researchers will determine if a larger, long-term study to test whether niacinamide slows progression of PKD is justified.

Conditions

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Polycystic Kidney Disease

Keywords

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PKD niacinamide Vitamin B3 Vitamin B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Niacinamide

All subjects in this study will take niacinamide at a dose of 30 mg per kilogram of body weight by mouth daily, in two divided daily doses, for 12 months.

Group Type EXPERIMENTAL

Niacinamide

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Niacinamide

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin B3

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of autosomal dominant polycystic kidney disease
* eGFR \> 90ml/min/1.73m2 as determined from the serum creatinine by the CKD-EPI equation
* Ability to give informed consent in English

Exclusion Criteria

* History of liver disease or abnormal liver function test
* Heavy alcohol intake
* Chronic diarrhea or malabsorption syndrome
* Thrombocytopenia
* Hypophosphatemia
* Pregnancy or lactation or plan to become pregnant during the study
* Treatment with anti-epileptic drugs
* Treatment with tolvaptan, current or within 2 months prior to screening
* Participation in another interventional trial currently or within 30 days prior to screening
* Partial or total nephrectomy or renal cyst reduction (including aspiration) done \<1 year ago
* Cardiac pacemaker
* Presence of magnetic resonance-incompatible metallic clips (e.g. clipped cerebral aneurysm)
* Body weight \>159 kg (350 lbs) or untreatable claustrophobia
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alan Yu, MB, BChir

OTHER

Sponsor Role lead

Responsible Party

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Alan Yu, MB, BChir

Professor and Director, Kidney Institute

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alan S Yu, MB, BChir

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00000874

Identifier Type: -

Identifier Source: org_study_id