Curcumin in Kidney Transplant Recipients

A Pilot 12 Month, Randomized, Controlled Trial of Curcumin in Kidney Transplant Recipients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Disorder Related to Renal Transplantation
• Intervention / Treatment: Dietary supplement: Curcumin; Other: Placebo

Detailed Description

Kidney transplant recipients are at increased risk of death from cardiovascular disease (CVD). Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in kidney transplant recipients and contribute to the high incidence of CVD in this patient population. The most common cause of kidney transplant failure is interstitial fibrosis and tubular atrophy (IFTA). The incidence of IFTA is as high as 50% of kidney transplants at 1 year after transplantation. The pathophysiology of IFTA is not well understood. Possible mechanisms include chronic rejection or injury, inflammation, and drug toxicity. Kidney transplant recipients suffer from high rates of cognitive decline for which the investigators lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment are a priority.

Curcumin may have positive effects in terms of cardiovascular and nephroprotection because of its antibacterial, antiviral, anti-inflammatory and anti-oxidative effects. The aim of this study is to elucidate the role of curcumin as a nutritional strategy to reduce cardiovascular risk factors as well as inflammation and oxidative stress in kidney transplant recipients. The study aims to examine if curcumin will improve endothelial function by reducing markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in kidney transplant recipients.

Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. Preliminary data indicate that curcumin administration improves endothelial dysfunction by reducing oxidative stress and inflammation and may improve cognitive function.

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.

Objectives:

1. Evaluate the effects of curcumin on kidney transplant graft function
2. Evaluate the effects of curcumin supplementation on cognitive function.
3. Evaluate the effects of curcumin on diabetes and cardiovascular outcomes
4. Evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress.

Methods:

Patients will be randomized 1:1 to receive either curcumin or placebo starting at the time of transplant or up to 2 weeks prior to transplant. Patients will be followed per standard of care for kidney transplant recipients. Additional blood (30mL) and urine samples will be drawn prior to transplant and at 3, 6 and 12 months post-transplant to be used for future analysis. There will be a total of 4 visits for this study. Additionally, two questionnaires will be distributed at each visit.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott T Benken, PharmD; Phone Number: 312-996-5695; Email: benken@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is a recipient of a living donor or deceased donor kidney only transplant
2. The subject is > 18 years of age

Exclusion Criteria:

1. The subject has had a multi-organ transplant
2. Subjects that were taking curcumin pre-transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin Arm (Arm 1); 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; Patients will receive curcumin 2000 mg a day, for 12 months; Other Names: Longvida
Placebo Comparator: Placebo Arm (Arm 2); 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; Patients will receive placebo capsule identical in appearance and taste to the supplement, for 12 months; Other Names: Longvida

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Verdure Sciences
• Investigators: Principal Investigator: Pierpaolo Di Cocco, MD, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Transplantation. 2006 Sep 15;82(5):715. Cruz-Corerra, Marcia [corrected to Cruz-Correa, Marcia].

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: kidney transplantation; inflammation; oxidative stress; cognitive impairment; graft function; vascular dysfunction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 2019-0321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No