Curcumin in Kidney Transplant Recipients

Disorder Related to Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03935958
• Other study ID #: 2019-0321
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: May 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation

Intervention

Dietary Supplement:
• Curcumin
Patients will receive curcumin 2000 mg a day, for 12 months

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

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Verdure Sciences

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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]. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft Outcomes	Change in GFR at 3, 6 and 12 months	12 months
Primary	Cognitive function & Pain	Change in Neuro-QOL Item Bank v2.0 at 0, 3, 6, and 12 months	12 months
Primary	Graft Outcomes	Difference in biopsy scores at 3 and 12 months	12 months
Primary	Cognitive function & Pain	Global Pain Scale at 0, 3, 6, and 12 months	12 months
Primary	Inflammation and oxidative stress	Markers of inflammation and oxidative stress at 0,3,6, & 12 months	12 months