Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)

Completed · Phase 2 · Has a placebo group

Conditions studied: Polycystic Kidney Disease

In brief

The purpose of this study is to observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.

Key facts

Study ID

NCT02558595

Run by

University of Kansas Medical Center

People needed

36

Starts

2015-09-22

Expected to finish

2017-12-18

Last updated by the study team

2019-02-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of autosomal dominant polycystic kidney disease (ADPKD).
• Estimated glomerular filtration rate (eGFR) > 50 ml/min/1.73m2 as determined from the serum creatinine by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
• Provide Informed consent

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 2 months prior to screening.
• Exclusions specific to magnetic resonance (MR) imaging acquisition and measurement:
• Partial or total nephrectomy or renal cyst reduction (including aspiration) done <1 year ago
• Cardiac pacemaker.
• Presence of MR 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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