Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD

NCT02494141 | Completed Phase 4 Results DMC

• 1 other identifier: 15-0902
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with autosomal dominant polycystic kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.

Conditions

Polycystic Kidney, Autosomal Dominant

Outcome Measures

Primary Outcomes (2)

• Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)

  co-primary endpoint

  Baseline, Month 12

• Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)

  co-primary endpoint

  Baseline, Month 12

Secondary Outcomes (5)

• Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)

  Baseline, Month 12

• Change in C-reactive Protein

  Baseline, Month 12

• Change in Interleukin-6

  Baseline, Month 12

• Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)

  Baseline, Month 12

• Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness

  Baseline, Month 12

Other Outcomes (3)

• Change in Alanine Transaminase (ALT )

  month 1, 6, and 12

• Change in Aspartate Aminotransferase (AST)

  month 1, 6, and 12

• Change in Height-corrected Total Kidney Volume

  Baseline, Month 12

Study Arms (2)

Curcumin

EXPERIMENTAL

25/mg/kg per day for 1 year.

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

Equivalent placebo for 1 year.

Other: Placebo

Interventions

Curcumin DRUG

Dietary Supplement

Also known as: Longvida

Curcumin

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ADPKD diagnosis
• Normal renal function (estimated glomerular filtration rate \>80 mL/min/1.73m\^2)
• Ability to provide informed consent

You may not qualify if:

• Currently taking a curcumin supplement
• Current smoking or history of smoking in the past 12 months
• Marijuana use within 2 weeks prior to FMDBA and aPWV testing
• Antioxidantand/or omega-3 fatty acid use within the past 4 weeks prior to FMDBA and aPWV testing and for the duration of the study
• Alcohol dependence and abuse
• History of hospitalization within the last 3 months
• Active infection or antibiotic therapy
• Pregnancy, lactation, or unwillingness to use adequate birth control
• Body-mass index \>95th percentile in ages 6-17 or \>40 kg/m2 in ages 18-25
• Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Nowak KL, Farmer-Bailey H, Wang W, You Z, Steele C, Cadnapaphornchai MA, Klawitter J, Patel N, George D, Jovanovich A, Soranno DE, Gitomer B, Chonchol M. Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Feb;17(2):240-250. doi: 10.2215/CJN.08950621. Epub 2021 Dec 14.

  PMID: 34907021 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Kristen Nowak, Ph.D.
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Kristen L Nowak, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 10, 2015
• Study Start: November 12, 2015
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)