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

Completed · Phase 2

Conditions studied: Polycystic Kidney Disease

In brief

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.

Key facts

Study ID

NCT02140814

Run by

Alan Yu, MB, BChir

People needed

10

Starts

2014-05-01

Last updated by the study team

2016-12-01

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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