Role of Coenzyme Q10 in Chronic Kidney Disease

NCT05942027 | Recruiting Phase 4

• 1 other identifier: Coenzyme Q10 in CKD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium \< 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups. Group 1: Control group Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control. Group 2: Coenzyme Q10 Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day. The dose of ramipril may be modified according to blood pressure control. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.

Conditions

Chronic Kidney Diseases

Keywords

Proteinuria, Bone Metabolism, Coenzyme Q10

Outcome Measures

Primary Outcomes (7)

• The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021

  Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021.

  The study duration will be 6 months.

• The change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g)

  Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration (mg/g)

  The study duration will be 6 months

• The change in blood pressure (mmHg) will be done using a mercury sphygmomanometer

  Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks.

  The study duration will be 6 months

• The change in Blood urea nitrogen (BUN) (mg/dl)

  Assessment of BUN (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI

  The study duration will be 6 months

• The change in serum potassium (meq/l).

  Assessment of serum potassium (meq/l) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI

  The study duration will be 6 months

• The change in serum creatinine (mg/dl)

  Assessment of serum creatinine (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI

  The study duration will be 6 months

• The change in serum urea (mg/dl)

  Assessment of serum urea (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI

  The study duration will be 6 months

Secondary Outcomes (6)

• The change in chronic kidney disease-mineral and bone disorder related parameters by assessment Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml)

  The study duration will be 6 months.

• The change in I-PTH (pg/ml)

  The study duration will be 6 months

• The change in vitamin D level (ng/ml)

  The study duration will be 6 months

• The change in serum calcium level (mg/dl)

  The study duration will be 6 months

• The change in serum phosphorus level (mg/dl)

  The study duration will be 6 months.

Study Arms (2)

Group 1: Control group

PLACEBO COMPARATOR

Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.

Drug: Placebo

Group 2: Coenzyme Q10

ACTIVE COMPARATOR

Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day.The dose of ramipril may be modified according to blood pressure control. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.

Drug: Co-Enzyme Q10

Interventions

Placebo DRUG

Placebo match Coenzyme Q10 capsules once per day .

Group 1: Control group

Co-Enzyme Q10 DRUG

Patients will be treated with Coenzyme Q10 capsules (CoQ10) 200 mg/day.

Group 2: Coenzyme Q10

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old.
• Both sexes.
• Patients matched in the duration of CKD.
• Non-dialysis chronic kidney disease (CKD) patient with estimated glomerular filtration rate (GFR) 30-89 mL/min/1.73m2 (Stage 2-3b).
• Patients with albumin-to-creatinine ratio ≥ 30 mg/g.
• Patients with serum Potassium \< 5 mEq/L.
• A newly diagnosed patients with hypertension.

You may not qualify if:

• Patients with elevated level of potassium ≥ 5 mEq/L.
• Patients with diabetes.
• Patients with cancer.
• Patients with heart disease.
• Patients with hepato-biliary disease and other liver diseases.
• Patients with kidney stones and urinary tract infection.
• Patients with an overactive thyroid gland.
• Patients with bleeding disorder.
• History of drug allergy to ACEI or ARBs.
• Pregnant and breastfeeding women.
• Patients with blood pressure ≥180/110 or \<100/60.
• Patients on alteplase, azothiopurine, everolimus, sirolimus, lithium, non-steroidal anti-inflammatory drugs (epifenac, tenoxicam, Celecoxib….), potassium retentive diuretics (amiloride, spironolactone), other ACEIs and ARBs will be excluded to avoid possible drug-drug interactions with ramipril.
• Patients on omega-3 fatty acids; vitamins (especially A, C, E, K), Chemotherapy and oral anticoagulant (warfarin), cholestyramine, orlistate will be excluded to avoid possible drug interactions that could affect Coenzyme Q10

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy Tanta University

Tanta, Capital of Gharbia Governorate., 31527, Egypt

RECRUITING

Related Publications (9)

• GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.

  PMID: 32061315 BACKGROUND

• Levey AS, de Jong PE, Coresh J, El Nahas M, Astor BC, Matsushita K, Gansevoort RT, Kasiske BL, Eckardt KU. The definition, classification, and prognosis of chronic kidney disease: a KDIGO Controversies Conference report. Kidney Int. 2011 Jul;80(1):17-28. doi: 10.1038/ki.2010.483. Epub 2010 Dec 8.

  PMID: 21150873 BACKGROUND

• Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. JAMA. 2011 Jun 15;305(23):2432-9. doi: 10.1001/jama.2011.826.

  PMID: 21673295 BACKGROUND

• Shimada T, Hasegawa H, Yamazaki Y, Muto T, Hino R, Takeuchi Y, Fujita T, Nakahara K, Fukumoto S, Yamashita T. FGF-23 is a potent regulator of vitamin D metabolism and phosphate homeostasis. J Bone Miner Res. 2004 Mar;19(3):429-35. doi: 10.1359/JBMR.0301264. Epub 2003 Dec 29.

  PMID: 15040831 BACKGROUND

• Sarafidis PA, Khosla N, Bakris GL. Antihypertensive therapy in the presence of proteinuria. Am J Kidney Dis. 2007 Jan;49(1):12-26. doi: 10.1053/j.ajkd.2006.10.014.

  PMID: 17185142 BACKGROUND

• Yeung CK, Billings FT 4th, Claessens AJ, Roshanravan B, Linke L, Sundell MB, Ahmad S, Shao B, Shen DD, Ikizler TA, Himmelfarb J. Coenzyme Q10 dose-escalation study in hemodialysis patients: safety, tolerability, and effect on oxidative stress. BMC Nephrol. 2015 Nov 3;16:183. doi: 10.1186/s12882-015-0178-2.

  PMID: 26531095 BACKGROUND

• FABRE LF Jr, BANKS RC, MCISAAC WM, FARRELL G. EFFECTS OF UBIQUINONE AND RELATED SUBSTANCES ON SECRETION OF ALDOSTERONE AND CORTISOL. Am J Physiol. 1965 Jun;208:1275-80. doi: 10.1152/ajplegacy.1965.208.6.1275. No abstract available.

  PMID: 14301392 BACKGROUND

• Heeringa SF, Chernin G, Chaki M, Zhou W, Sloan AJ, Ji Z, Xie LX, Salviati L, Hurd TW, Vega-Warner V, Killen PD, Raphael Y, Ashraf S, Ovunc B, Schoeb DS, McLaughlin HM, Airik R, Vlangos CN, Gbadegesin R, Hinkes B, Saisawat P, Trevisson E, Doimo M, Casarin A, Pertegato V, Giorgi G, Prokisch H, Rotig A, Nurnberg G, Becker C, Wang S, Ozaltin F, Topaloglu R, Bakkaloglu A, Bakkaloglu SA, Muller D, Beissert A, Mir S, Berdeli A, Varpizen S, Zenker M, Matejas V, Santos-Ocana C, Navas P, Kusakabe T, Kispert A, Akman S, Soliman NA, Krick S, Mundel P, Reiser J, Nurnberg P, Clarke CF, Wiggins RC, Faul C, Hildebrandt F. COQ6 mutations in human patients produce nephrotic syndrome with sensorineural deafness. J Clin Invest. 2011 May;121(5):2013-24. doi: 10.1172/JCI45693. Epub 2011 Apr 11.

  PMID: 21540551 BACKGROUND

• Alehagen U, Aaseth J, Larsson A, Alexander J. Decreased Concentration of Fibroblast Growth Factor 23 (FGF-23) as a Result of Supplementation with Selenium and Coenzyme Q10 in an Elderly Swedish Population: A Sub-Analysis. Cells. 2022 Feb 1;11(3):509. doi: 10.3390/cells11030509.

  PMID: 35159318 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Central Study Contacts

Dina Abdel Hamid, Masters

CONTACT

+2001020198970; pg_87899@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 12, 2023
• Study Start: July 15, 2023
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)