Polycystic Kidney, Autosomal DominantPhase 4NCT02494141
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
A Phase 4 study testing Curcumin in people with Polycystic Kidney, Autosomal Dominant, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with autosomal dominant polycystic kidney disease (ADPKD). Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2015to 1 Feb 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ADPKD diagnosis
- Normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m^2)
- Ability to provide informed consent
Who cannot join
- Currently taking a curcumin supplement
- Current smoking or history of smoking in the past 12 months
- Marijuana use within 2 weeks prior to FMDBA and aPWV testing
- Antioxidantand/or omega-3 fatty acid use within the past 4 weeks prior to FMDBA and aPWV testing and for the duration of the study
- Alcohol dependence and abuse
- History of hospitalization within the last 3 months
Show all 10Show fewer
- Active infection or antibiotic therapy
- Pregnancy, lactation, or unwillingness to use adequate birth control
- Body-mass index >95th percentile in ages 6-17 or >40 kg/m2 in ages 18-25
- Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with autosomal dominant polycystic kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.
Read the detailed description
Although often considered to be a disease of adults, complications of autosomal dominant polycystic kidney disease (ADPKD) begin in childhood. While ADPKD causes the continued growth of multiple kidney cysts that ultimately result in loss of kidney function, the leading cause of death among patients with ADPKD is cardiovascular disease. Treatment options to prevent cardiovascular disease in adults with ADPKD are limited, thus childhood may be an important time to reduce risk. Curcumin is a safe, naturally occurring substance found in the Indian spice tumeric, which is in curry powder. The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with ADPKD. The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Being tested
- Curcumin, Placebo
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Longvida
Dietary Supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | 25/mg/kg per day for 1 year. Receives: Drug: Curcumin |
| Placebo | Placebo comparator | Equivalent placebo for 1 year. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)
co-primary endpoint
Measured: Baseline, Month 12
Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)
co-primary endpoint
Measured: Baseline, Month 12
Secondary outcomes (5)
Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)
Urine marker of oxidative stress. Values are normalized to urinary creatinine.
Measured: Baseline, Month 12
Change in C-reactive Protein
Circulating marker of inflammation
Measured: Baseline, Month 12
Change in Interleukin-6
Circulating marker of inflammation
Measured: Baseline, Month 12
Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)
The influence of oxidative stress on FMD-BA will be determined by infusing a supraphysiological dose of ascorbic acid known to scavenge superoxide or isovolumic saline. The outcome measure describes the value of the percent change with ascorbic acid compared to saline observed at baseline and the value of the percent change with ascorbic acid compared to saline at the month 12 timepoint.
Measured: Baseline, Month 12
Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness
The influence of oxidative stress on aPWV will be determined by infusing a supraphysiological dose of ascorbic acid known to scavenge superoxide or isovolumic saline.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start12 Nov 2015
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney, Autosomal DominantStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen L Nowak, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494141
- Sponsor's protocol ID
- 15-0902
- Status last verified
- Feb 2022
- First submitted
- 25 Jun 2015
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Nowak KL, Farmer-Bailey H, Wang W, You Z, Steele C, Cadnapaphornchai MA, Klawitter J, Patel N, George D, Jovanovich A, Soranno DE, Gitomer B, Chonchol M. Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Feb;17(2):240-250. doi: 10.2215/CJN.08950621. Epub 2021 Dec 14.
PubMed 34907021
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
- ClinicalTrials.gov ID
- NCT02494141
- Acronym / sponsor ID
- 15-0902
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with autosomal dominant polycystic kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.
Detailed description
Although often considered to be a disease of adults, complications of autosomal dominant polycystic kidney disease (ADPKD) begin in childhood. While ADPKD causes the continued growth of multiple kidney cysts that ultimately result in loss of kidney function, the leading cause of death among patients with ADPKD is cardiovascular disease. Treatment options to prevent cardiovascular disease in adults with ADPKD are limited, thus childhood may be an important time to reduce risk. Curcumin is a safe, naturally occurring substance found in the Indian spice tumeric, which is in curry powder. The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with ADPKD. The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: Curcumin25/mg/kg per day for 1 year. |
| Placebo | Placebo comparator | Other: PlaceboEquivalent placebo for 1 year. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ADPKD diagnosis
- Normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m^2)
- Ability to provide informed consent
Key exclusion criteria (10 listed)
- Currently taking a curcumin supplement
- Current smoking or history of smoking in the past 12 months
- Marijuana use within 2 weeks prior to FMDBA and aPWV testing
- Antioxidantand/or omega-3 fatty acid use within the past 4 weeks prior to FMDBA and aPWV testing and for the duration of the study
- Alcohol dependence and abuse
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 |
|---|---|---|
| CurcuminAlso: LongvidaDietary Supplement | Drug | Curcumin |
| Placebo | Other | Placebo |
Primary outcome
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)
Time frame: Baseline, Month 12
co-primary endpoint
Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)
Time frame: Baseline, Month 12
co-primary endpoint
5 secondary outcomes
Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)
Time frame: Baseline, Month 12
Change in C-reactive Protein
Time frame: Baseline, Month 12
Change in Interleukin-6
Time frame: Baseline, Month 12
Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)
Time frame: Baseline, Month 12
Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34907021Nowak KL, Farmer-Bailey H, Wang W, You Z, Steele C, Cadnapaphornchai MA, Klawitter J, Patel N, George D, Jovanovich A, Soranno DE, Gitomer B, Chonchol M. Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Feb;17(2):240-250. doi: 10.2215/CJN.08950621. Epub 2021 Dec 14.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Kristen L Nowak, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Curcumin in people with Polycystic Kidney, Autosomal Dominant, run by University of Colorado, Denver at 1 site in United States.
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 3 inclusion and 10 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA) (time frame: Baseline, Month 12). 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 NCT02494141, which also lists 1 linked publication.
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 3 Mar 2022.