Chronic Kidney DiseasePhase 3MPAC-CKDNCT02369549
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
A Phase 3 study testing Micro-particle Curcumin in people with Chronic Kidney Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
Trial summary
An investigator initiated pilot trial: two arm, double blind, placebo controlled, randomized, parallel group of approximately 750 patients with chronic kidney disease, and who have evidence of overt proteinuria, will be treated with micro-particle curcumin versus placebo over 24 weeks from start of the investigational… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Micro-particle Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 2015to 15 May 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eGFR between 15 and 60 ml/min/1.73 m2;
- Albuminuria, defined by the most recent measurement within the prior 3 months showing either: a) 24-hour urine collection with a minimum of 300 mg of protein, OR b) urinary albumin to creatinine ratio equivalent to a daily excretion of albumin of at least 300 mg;
- If diabetic, is able and willing to take and record glucose levels at home;
- If receiving and ACE inhibitor or angiotension II receptor blocker (ARB), the dosage must be stable for 2 weeks prior to screening. Patients not taking and ACE or ARB must have a documented medical contraindication (e.g. hyperkalemia, hypotension);
- Willing and able to give written informed consent for participation and provide consent for access to medical data according to local data protection laws and regulations.
Who cannot join
- Life expectancy < 1 year;
- Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom);
- Known allergy to ingredients of the study product or placebo (microcrystalline cellulose, vegetarian capsule, vegetable grade magnesium stearate, silica;
- Pregnant or breastfeeding;
- Women of child-bearing potential who are not either surgically sterile or not postmenopausal for at least 1 year;
- Plans for transplantation during the study period;
Show all 16Show fewer
- Receipt of hemodialysis or peritoneal dialysis in the past 3 months;
- Active peptic ulcer disease;
- Hepatobiliary disease in the past 4 weeks;
- Evidence of acute kidney injury (>50% increase in serum creatinine in the past 30 days);
- History of significant bleeding (GI or retroperitoneal bleed requiring transfusion, or any intracranial hemorrhage in the past 6 months);
- Ongoing use of warfarin;
- Ongoing treatment with cyclophosphamide, camptothecin, mechlorethamine or doxorubicin;
- Ongoing use of anti-psychotic medication including haloperidol, aripiprazole, risperidone, ziprasidone, pimozide, and quetiapine;
- Previous participation in MPAC-CKD;
- Current participation on another investigational medication trial.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Population Health Research Institute
Hamilton, Ontario, L8L 0A6
Kidney Clinical Care Unit
London, Ontario, N6A 5A5
University Hospital
London, Ontario, N6A 5A5
Victoria Hospital
London, Ontario, N6A 5W9
About this study
An investigator initiated pilot trial: two arm, double blind, placebo controlled, randomized, parallel group of approximately 750 patients with chronic kidney disease, and who have evidence of overt proteinuria, will be treated with micro-particle curcumin versus placebo over 24 weeks from start of the investigational medication date (approximately 6 months) to test whether curcumin can slow chronic kidney disease progression in patients. Three 30 mg capsules of micro-particle curcumin will be self-administered once daily in the morning to determine the the safety and efficacy of curcumin relative to placebo in reducing albuminuria and slowing the loss of eGFR.
Read the detailed description
Limiting the progression from CKD to end-stage renal disease is one of the most important goals in kidney medicine. The evidence implicating inflammation and fibrosis in that process is strong, and there is abundant mechanistic and animal model data to show that curcumin is a potent inhibitor of both inflammation and fibrosis. Two preliminary randomized trials in human CKD hint at curcumin's enormous therapeutic potential in CKD. The Principal Investigator/Sponsor will rigorously test this potential in a broadly selected sample of up to 750 patients with CKD. Compared to previous studies, this study's results will be generalizable across other etiologies of CKD and with a larger sample size; this study will provide more precise estimates of curcumin's benefits and risks. Also, this study proposes to use a new, micro-particle formulation of curcumin that is highly bioavailable. The Principal Investigator/Sponsor will assess curcumin's effects on three key markers of kidney health that encompass the cardinal functions of the nephron. Positive results from MPAC-CKD will lay solid scientific ground-work for a multi-centre trial capable of testing micro-particle curcumin's effect of the most meaningful outcomes: death and the development of end-stage renal disease.
To ensure that this study will have the necessary adherence and tolerability data, up to 750 patients with proteinuric CKD will be randomly assigned to 90 mg per day of micro-particle curcumin or matching placebo, for a total of 24 weeks (approximately 6 months). In the last few years, new formulations of curcumin have been shown to substantially augment absorption by improving its aqueous solubility. The micro-particle formulation of curcumin is one of these new formulations and is the only curcumin delivery system proven to increase bioavailability. Compared to traditional curcumin, micro-particle curcumin achieves total serum concentrations that are 27 fold higher. In this study, micro-particle curcumin will allow the study team to administer the equivalent of 3000 mg of traditional curcumin (which would require six 500 mg capsules daily), in a single 90 mg capsule. In addition, as opposed to traditional curcumin, there is no requirement to take micro-particle curcumin on a full stomach. The Investigator/Sponsor has selected a dose equivalent to 3 grams per day of curcumin because this is within the range of doses proven safe and effective and it will minimize pill burden by allowing the full daily dose to be achieved by three small 30 mg capsules daily In rare cases, curcumin has been reported to cause minor nausea, headache, diarrhea, yellow stool, and temporary giddiness. All unexpected reactions reported in previous studies were easily managed and happened at higher doses than what will be used in MPAC-CKD.
This study will assess two primary outcomes: the 6-month change in albuminuria, and the 6-month change in eGFR.
Secondary outcomes will include health-related quality of life, glycemic control among patients with diabetes mellitus, and a composite of progressive CKD, ESRD and death. The investigators will also measure serum curcumin levels in the first 30 randomized participants, who will have a 4.5 ml blood sample taken at the 12 week (3 month) visit. This sample will be processed and stored at -80 degrees C. for batch testing for plasma micro-particle curcumin concentrations.
The investigators will conduct a subgroup analysis based on participants 2-year risk of requiring dialysis using the validated Kidney Failure Risk Equation to group patients into a high risk group (10% or greater risk of dialysis within 2 years) and low risk group (<10% risk within 2 years).
Medical history, lab values and vitals will be collected and/or updated at each in-person visit. Each participant will be provided with instructions and study schedule. Participants with diabetes mellitus will be given a home glucose log-book.
Protocol compliance will be tested through pill counts and interviews at each follow-up visit. Side effects will be assessed using standardized case report forms at each visit. Participants will be contacted by telephone one week into the trial and then once every 4 weeks (monthly) for 28 weeks (approximately 7 months) for safety monitoring and reporting and to reinforce importance of compliance. In-person visits will occur at 12 and 24 weeks (approximately 3 and 6 months) after randomization and the start of the investigational medication, at which time investigational medication will be counted and supply replenished. First morning at-home urine specimens will be collected at baseline and again arranged at the in-person visits at 12 and 24 weeks (approximately 3 and 6 months). Participants will also be encouraged to report any events they may experience directly to the coordinator(s) and/or PI.
Participants who withdraw consent to continue treatments, will be encouraged to undergo the planned assessments. Withdrawal at the request of investigators or medical personnel may include, but are not limited to:
- Symptoms are deemed to be potentially related to the sue of the investigational medication;
- New diagnosis of exclusion criteria;
- Inter-current illness not related to the use of the investigational Natural Health Product (NHP) medication;
- Unacceptable side effects;
- Death;
- Improved health status.
Estimated time to complete recruitment: Averaging 136 weeks, approximately 34 months.
Long-term outcomes will be tracked using administrative data housed at The Institute for Clinical Evaluative Sciences (ICES), an independent research facility in Toronto, Ontario. ICES works with the Ontario Ministry of Health and Long-Term Care to study the impact of health care and diseases in Ontario.
A panel of external experts and study investigators will comprise the Steering Committee and will ensure the integrity of the study. They will be responsible for reviewing and acting upon the recommendations of the Data Safety Monitoring Board, amendments to the protocol, oversight of publication and dissemination of study results.
- Conditions
- Chronic Kidney Disease
- Being tested
- Micro-particle Curcumin, Placebo
- Keywords
- Chronic Kidney Disease (CKD), Micro-particle curcumin, Albuminuria
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-particle CurcuminDrug
Also called Theracumin-Pro 300
as described in Arm
PlaceboDrug
Looks, smells, tastes and feels exactly like the Curcumin capsules.
| Study group | Role | What they receive |
|---|---|---|
| Micro-particle curcumin | Active comparator | Three 30 mg capsules once daily, self-administered for 6 months.
Curcumin is a nutraceutical, which are products isolated or purified from foods. The rhizomes of the plant Curcuma longa produces turmeric, a spice commonly used in Indian cuisine. Turmeric is comprised of three curcuminoids, of which curcumin is the most abundant. Curcumin is a polyphenol molecule that has been investigated for anti-inflammatory and anti-neoplastic properties since the 1970s. Receives: Drug: Micro-particle Curcumin |
| Placebo | Placebo comparator | Three 30 mg capsules taken once daily, self-administered for 6 months.
Placebo capsules are identical to the curcumin capsules in color, taste, smell, size and shape. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in albuminuria from baseline to 24 week (6 month)
Albuminuria will be measured using urinary albumin-to-creatinine ratio from first morning urine samples. At each visit (pre-randomization, and 3- and 6-months post-randomization), urinary albumin-to-creatinine ratio is measured on two consecutive days and the average of the two values will be computed. The average of the two values will be log-transformed using the natural logarithm. Albuminuria is the cardinal manifestation of a malfunctioning filtration barrier and the spillage of albumin into renal tubules is thought to be toxic to tubular cells, resulting in further kidney damage. Therefore, in the current understanding, albuminuria is both a marker and a mediator of kidney damage. Reduction of albuminuria has repeatedly been associated with improved renal outcomes. Leaders in the field of nephrology recommend that albuminuria be used as a valuable predictor of response to therapy for the prevention of kidney failure.
Measured: Baseline and 24 weeks (6 months)
Change in Estimated Glomerular Filtration rate (eGFR) from baseline to 24 weeks (6 months)
eGFR will be calculated using the CKD-EPI formula. The investigators will estimate the between-group difference in change in eGFR (6-month eGFR minus baseline eGFR), expressed in mL/min per 1.73m2, using linear regression.
Measured: Baseline and 24 weeks (6 months)
Secondary outcomes (4)
Change in glycemic control among participants with diabetes mellitus
The investigators will summarize the percentage of glycated hemoglobin pre-randomization and 6-months post-randomization and will present the between-group difference in change in percentage of glycated hemoglobin (6-month value minus pre-randomization value) among patients with diabetes mellitus.
Measured: Baseline and 24 week (6 months)
Renal failure composite
The investigators will report on the outcome of progressive CKD, ESRD, and death, first as a composite outcome, and then as separate components. ESRD will be defined as an eGFR <15 mL/min/1.73 m2 or the initiation of renal replacement therapy, which includes chronic dialysis or transplantation; progressive CKD will be defined as an eGFR loss of ≥ 30% (anytime during follow-up from the pre-randomization baseline value) or ESRD. Less than 10% of participants will be expected to experience these outcomes by 6 months. The focus of this analysis is to document any trends to inform the expected event rate for future studies.
Measured: 24 week (6 months)
Change in health-related quality of life (physical composite summary)
Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The physical composite summary (PCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.
Measured: Baseline and 24 week (6 months)
Change in health-related quality of life (mental composite summary)
Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The mental composite summary (MCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.
Measured: Baseline and 24 week (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2019
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Kidney Foundation of Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Matthew Weir, Nephrologist, Principal investigator, LHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369549
- Sponsor's protocol ID
- MPAC-CKD
- Acronym
- MPAC-CKD
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2015
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Weir MA, Walsh M, Cuerden MS, Sontrop JM, Urquhart BL, Lim YJ, Chambers LC, Garg AX. The effect of micro-particle curcumin on chronic kidney disease progression: the MPAC-CKD randomized clinical trial. Nephrol Dial Transplant. 2023 Sep 29;38(10):2192-2200. doi: 10.1093/ndt/gfad037.
PubMed 36849161Weir MA, Walsh M, Cuerden MS, Sontrop JM, Chambers LC, Garg AX. Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease-1: Study Protocol for a Multicenter Clinical Trial. Can J Kidney Health Dis. 2018 Dec 5;5:2054358118813088. doi: 10.1177/2054358118813088. eCollection 2018.
PubMed 30619615
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02369549
- Acronym / sponsor ID
- MPAC-CKD / MPAC-CKD
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease (CKD), Micro-particle curcumin, Albuminuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Kidney Foundation of Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigator initiated pilot trial: two arm, double blind, placebo controlled, randomized, parallel group of approximately 750 patients with chronic kidney disease, and who have evidence of overt proteinuria, will be treated with micro-particle curcumin versus placebo over 24 weeks from start of the investigational medication date (approximately 6 months) to test whether curcumin can slow chronic kidney disease progression in patients. Three 30 mg capsules of micro-particle curcumin will be self-administered once daily in the morning to determine the the safety and efficacy of curcumin relative to placebo in reducing albuminuria and slowing the loss of eGFR.
Detailed description
Limiting the progression from CKD to end-stage renal disease is one of the most important goals in kidney medicine. The evidence implicating inflammation and fibrosis in that process is strong, and there is abundant mechanistic and animal model data to show that curcumin is a potent inhibitor of both inflammation and fibrosis. Two preliminary randomized trials in human CKD hint at curcumin's enormous therapeutic potential in CKD. The Principal Investigator/Sponsor will rigorously test this potential in a broadly selected sample of up to 750 patients with CKD. Compared to previous studies, this study's results will be generalizable across other etiologies of CKD and with a larger sample size; this study will provide more precise estimates of curcumin's benefits and risks. Also, this study proposes to use a new, micro-particle formulation of curcumin that is highly bioavailable. The Principal Investigator/Sponsor will assess curcumin's effects on three key markers of kidney health that encompass the cardinal functions of the nephron. Positive results from MPAC-CKD will lay solid scientific ground-work for a multi-centre trial capable of testing micro-particle curcumin's effect of the most meaningful outcomes: death and the development of end-stage renal disease.
To ensure that this study will have the necessary adherence and tolerability data, up to 750 patients with proteinuric CKD will be randomly assigned to 90 mg per day of micro-particle curcumin or matching placebo, for a total of 24 weeks (approximately 6 months). In the last few years, new formulations of curcumin have been shown to substantially augment absorption by improving its aqueous solubility. The micro-particle formulation of curcumin is one of these new formulations and is the only curcumin delivery system proven to increase bioavailability. Compared to traditional curcumin, micro-particle curcumin achieves total serum concentrations that are 27 fold higher. In this study, micro-particle curcumin will allow the study team to administer the equivalent of 3000 mg of traditional curcumin (which would require six 500 mg capsules daily), in a single 90 mg capsule. In addition, as opposed to traditional curcumin, there is no requirement to take micro-particle curcumin on a full stomach. The Investigator/Sponsor has selected a dose equivalent to 3 grams per day of curcumin because this is within the range of doses proven safe and effective and it will minimize pill burden by allowing the full daily dose to be achieved by three small 30 mg capsules daily In rare cases, curcumin has been reported to cause minor nausea, headache, diarrhea, yellow stool, and temporary giddiness. All unexpected reactions reported in previous studies were easily managed and happened at higher doses than what will be used in MPAC-CKD.
This study will assess two primary outcomes: the 6-month change in albuminuria, and the 6-month change in eGFR.
Secondary outcomes will include health-related quality of life, glycemic control among patients with diabetes mellitus, and a composite of progressive CKD, ESRD and death. The investigators will also measure serum curcumin levels in the first 30 randomized participants, who will have a 4.5 ml blood sample taken at the 12 week (3 month) visit. This sample will be processed and stored at -80 degrees C. for batch testing for plasma micro-particle curcumin concentrations.
The investigators will conduct a subgroup analysis based on participants 2-year risk of requiring dialysis using the validated Kidney Failure Risk Equation to group patients into a high risk group (10% or greater risk of dialysis within 2 years) and low risk group (<10% risk within 2 years).
Medical history, lab values and vitals will be collected and/or updated at each in-person visit. Each participant will be provided with instructions and study schedule. Participants with diabetes mellitus will be given a home glucose log-book.
Protocol compliance will be tested through pill counts and interviews at each follow-up visit. Side effects will be assessed using standardized case report forms at each visit. Participants will be contacted by telephone one week into the trial and then once every 4 weeks (monthly) for 28 weeks (approximately 7 months) for safety monitoring and reporting and to reinforce importance of compliance. In-person visits will occur at 12 and 24 weeks (approximately 3 and 6 months) after randomization and the start of the investigational medication, at which time investigational medication will be counted and supply replenished. First morning at-home urine specimens will be collected at baseline and again arranged at the in-person visits at 12 and 24 weeks (approximately 3 and 6 months). Participants will also be encouraged to report any events they may experience directly to the coordinator(s) and/or PI.
Participants who withdraw consent to continue treatments, will be encouraged to undergo the planned assessments. Withdrawal at the request of investigators or medical personnel may include, but are not limited to:
- Symptoms are deemed to be potentially related to the sue of the investigational medication;
- New diagnosis of exclusion criteria;
- Inter-current illness not related to the use of the investigational Natural Health Product (NHP) medication;
- Unacceptable side effects;
- Death;
- Improved health status.
Estimated time to complete recruitment: Averaging 136 weeks, approximately 34 months.
Long-term outcomes will be tracked using administrative data housed at The Institute for Clinical Evaluative Sciences (ICES), an independent research facility in Toronto, Ontario. ICES works with the Ontario Ministry of Health and Long-Term Care to study the impact of health care and diseases in Ontario.
A panel of external experts and study investigators will comprise the Steering Committee and will ensure the integrity of the study. They will be responsible for reviewing and acting upon the recommendations of the Data Safety Monitoring Board, amendments to the protocol, oversight of publication and dissemination of study results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-particle curcumin | Active comparator | Drug: Micro-particle CurcuminThree 30 mg capsules once daily, self-administered for 6 months. Curcumin is a nutraceutical, which are products isolated or purified from foods. The rhizomes of the plant Curcuma longa produces turmeric, a spice commonly used in Indian cuisine. Turmeric is comprised of three curcuminoids, of which curcumin is the most abundant. Curcumin is a polyphenol molecule that has been investigated for anti-inflammatory and anti-neoplastic properties since the 1970s. |
| Placebo | Placebo comparator | Drug: PlaceboThree 30 mg capsules taken once daily, self-administered for 6 months. Placebo capsules are identical to the curcumin capsules in color, taste, smell, size and shape. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- eGFR between 15 and 60 ml/min/1.73 m2;
- Albuminuria, defined by the most recent measurement within the prior 3 months showing either: a) 24-hour urine collection with a minimum of 300 mg of protein, OR b) urinary albumin to creatinine ratio equivalent to a daily excretion of albumin of at least 300 mg;
- If diabetic, is able and willing to take and record glucose levels at home;
- If receiving and ACE inhibitor or angiotension II receptor blocker (ARB), the dosage must be stable for 2 weeks prior to screening. Patients not taking and ACE or ARB must have a documented medical contraindication (e.g. hyperkalemia, hypotension);
- Willing and able to give written informed consent for participation and provide consent for access to medical data according to local data protection laws and regulations.
Key exclusion criteria (16 listed)
- Life expectancy < 1 year;
- Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom);
- Known allergy to ingredients of the study product or placebo (microcrystalline cellulose, vegetarian capsule, vegetable grade magnesium stearate, silica;
- Pregnant or breastfeeding;
- Women of child-bearing potential who are not either surgically sterile or not postmenopausal for at least 1 year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-particle CurcuminAlso: Theracumin-Pro 300as described in Arm | Drug | Micro-particle curcumin |
| PlaceboLooks, smells, tastes and feels exactly like the Curcumin capsules. | Drug | Placebo |
Primary outcome
Change in albuminuria from baseline to 24 week (6 month)
Time frame: Baseline and 24 weeks (6 months)
Albuminuria will be measured using urinary albumin-to-creatinine ratio from first morning urine samples. At each visit (pre-randomization, and 3- and 6-months post-randomization), urinary albumin-to-creatinine ratio is measured on two consecutive days and the average of the two values will be computed. The average of the two values will be log-transformed using the natural logarithm. Albuminuria is the cardinal manifestation of a malfunctioning filtration barrier and the spillage of albumin into renal tubules is thought to be toxic to tubular cells, resulting in further kidney damage. Therefore, in the current understanding, albuminuria is both a marker and a mediator of kidney damage. Reduction of albuminuria has repeatedly been associated with improved renal outcomes. Leaders in the field of nephrology recommend that albuminuria be used as a valuable predictor of response to therapy for the prevention of kidney failure.
Change in Estimated Glomerular Filtration rate (eGFR) from baseline to 24 weeks (6 months)
Time frame: Baseline and 24 weeks (6 months)
eGFR will be calculated using the CKD-EPI formula. The investigators will estimate the between-group difference in change in eGFR (6-month eGFR minus baseline eGFR), expressed in mL/min per 1.73m2, using linear regression.
4 secondary outcomes
Change in glycemic control among participants with diabetes mellitus
Time frame: Baseline and 24 week (6 months)
Renal failure composite
Time frame: 24 week (6 months)
Change in health-related quality of life (physical composite summary)
Time frame: Baseline and 24 week (6 months)
Change in health-related quality of life (mental composite summary)
Time frame: Baseline and 24 week (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 36849161Weir MA, Walsh M, Cuerden MS, Sontrop JM, Urquhart BL, Lim YJ, Chambers LC, Garg AX. The effect of micro-particle curcumin on chronic kidney disease progression: the MPAC-CKD randomized clinical trial. Nephrol Dial Transplant. 2023 Sep 29;38(10):2192-2200. doi: 10.1093/ndt/gfad037.
- Derived from this study: PubMed 30619615Weir MA, Walsh M, Cuerden MS, Sontrop JM, Chambers LC, Garg AX. Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease-1: Study Protocol for a Multicenter Clinical Trial. Can J Kidney Health Dis. 2018 Dec 5;5:2054358118813088. doi: 10.1177/2054358118813088. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Weir, Nephrologist principal investigator
LHSC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micro-particle Curcumin in people with Chronic Kidney Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in albuminuria from baseline to 24 week (6 month) (time frame: Baseline and 24 weeks (6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369549, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.