Curcumin in Kidney Transplant Recipients

NCT03935958 | Active Not Recruiting

• 1 other identifier: 2019-0321
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to investigate if curcumin is beneficial for kidney transplant recipients, a population with extensive baseline vascular dysfunction and cognitive impairment who have few treatment options. The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.

Conditions

Disorder Related to Renal Transplantation

Keywords

kidney transplantation; inflammation; vascular dysfunction; cognitive impairment; oxidative stress; graft function

Outcome Measures

Primary Outcomes (5)

• Graft Outcomes

  Change in GFR at 3, 6 and 12 months

  12 months

• Cognitive function & Pain

  Change in Neuro-QOL Item Bank v2.0 at 0, 3, 6, and 12 months

  12 months

• Graft Outcomes

  Difference in biopsy scores at 3 and 12 months

  12 months

• Cognitive function & Pain

  Global Pain Scale at 0, 3, 6, and 12 months

  12 months

• Inflammation and oxidative stress

  Markers of inflammation and oxidative stress at 0,3,6, \& 12 months

  12 months

Study Arms (2)

Curcumin Arm (Arm 1)

EXPERIMENTAL

20 subjects will be randomized (1:1) to this arm and receive curcumin for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood samples and questionnaires.

Dietary Supplement: Curcumin

Placebo Arm (Arm 2)

PLACEBO COMPARATOR

20 subjects will be randomized (1:1) to this arm and receive placebo for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood samples and questionnaires.

Other: Placebo

Interventions

Curcumin DIETARY_SUPPLEMENT

Patients will receive curcumin 2000 mg a day, for 12 months

Also known as: Longvida

Curcumin Arm (Arm 1)

Placebo OTHER

Patients will receive placebo capsule identical in appearance and taste to the supplement, for 12 months

Also known as: Longvida

Placebo Arm (Arm 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a recipient of a living donor or deceased donor kidney only transplant
• The subject is \> 18 years of age

You may not qualify if:

• The subject has had a multi-organ transplant
• Subjects that were taking curcumin pre-transplant

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Verdure Sciences: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

• Ali BH, Al-Salam S, Al Suleimani Y, Al Kalbani J, Al Bahlani S, Ashique M, Manoj P, Al Dhahli B, Al Abri N, Naser HT, Yasin J, Nemmar A, Al Za'abi M, Hartmann C, Schupp N. Curcumin Ameliorates Kidney Function and Oxidative Stress in Experimental Chronic Kidney Disease. Basic Clin Pharmacol Toxicol. 2018 Jan;122(1):65-73. doi: 10.1111/bcpt.12817. Epub 2017 Jul 10.

  PMID: 28561324 BACKGROUND

• Sun X, Liu Y, Li C, Wang X, Zhu R, Liu C, Liu H, Wang L, Ma R, Fu M, Zhang D, Li Y. Recent Advances of Curcumin in the Prevention and Treatment of Renal Fibrosis. Biomed Res Int. 2017;2017:2418671. doi: 10.1155/2017/2418671. Epub 2017 May 4.

  PMID: 28546962 BACKGROUND

• Shoskes D, Lapierre C, Cruz-Correa M, Muruve N, Rosario R, Fromkin B, Braun M, Copley J. Beneficial effects of the bioflavonoids curcumin and quercetin on early function in cadaveric renal transplantation: a randomized placebo controlled trial. Transplantation. 2005 Dec 15;80(11):1556-9. doi: 10.1097/01.tp.0000183290.64309.21.

  PMID: 16371925 BACKGROUND

MeSH Terms

Conditions

Inflammation; Cognitive Dysfunction

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pierpaolo Di Cocco, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will not know if they are receiving curcumin or placebo
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Surgery

Model Details: 20 participants in supplement (receiving curcumin) group 20 participants in control (receiving placebo) group randomization 1:1

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 2, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)