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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2016
• Main ID: NCT02140814
• Date of registration: 14/05/2014
• Prospective Registration: No
• Primary sponsor: Alan Yu, MB, BChir
• Public title: Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease NIAC-PKD1
• Scientific title: Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease
• Date of first enrolment: May 2014
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02140814
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Alan S Yu, MB, BChir
• Affiliation: University of Kansas Medical Center

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Polycystic Kidney Disease

Intervention(s)

Dietary Supplement: Niacinamide

Primary Outcome(s)

Sirtuin deacetylase activity [Time Frame: Change from Baseline to 12 Months]

Secondary Outcome(s)

Estimated Glomerular Filtration Rate (eGFR) [Time Frame: 12 Months]

Subject pain [Time Frame: Change from Baseline to 12 Months]

Biomarker levels [Time Frame: 12 Months]

Height-adjusted total kidney volumes (htTKV) [Time Frame: Change from Baseline to 12 Months]

Sirtuin deacetylase activity [Time Frame: Change from Baseline to 6 Months]

Secondary ID(s)

STUDY00000874

Source(s) of Monetary Support

Please refer to primary and secondary sponsors