HealthyNCT03661216
Evaluation of Nephure™, and the Reduction of Dietary Oxalate, in Healthy Volunteers
A study testing Nephure Oxalate-reducing Enzyme in people with Healthy, run by Captozyme, Inc. at 1 site in United States.
Trial summary
The purpose of this double-blind study is to determine the effect of reducing oxalates in the diet of healthy volunteers by using Nephure, an oxalate-reducing enzyme, as compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Healthy
- What is being tested?
- Nephure Oxalate-reducing Enzyme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2018to 5 Aug 2018
- Phase
- Interventional
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has granted written informed consent.
- Subject must be a male or non-pregnant female, at least 18 to 55 years of age at the time of Screening, and non-smoker for at least 3 months at the time of screening and throughout study.
- Subject has a BMI of 18.5 - 29.9 kg/m2 at the time of Screening.
- Subject has an estimated glomerular filtration rate (eGFR) of >90 mL/min/1.73 m2 at the time of Screening (GFR is calculated using the NIDDK provided equation at the following web address: www.niddk.nih.gov/health-information/communication-programs/nkdep/laboratory-evaluation/glomerular-filtration-rate-calculators/ckd-epi-adults-conventional-units.)
- Subject has a urinary oxalate <40.5mg/24 hours at the time of Screening .
- Subject has a urinary uric acid <750mg/24hour at the time of Screening1.
Show all 10Show fewer
- Subject is in good health as determined by complete physical examination, medical history, vital signs, and laboratory tests.
- Subject is able to understand the study and be able to comply to the requirements and restrictions, including agreeing to complete the 24-hour urine collections, and has the ability to report their symptoms.
- Subject is able to comply with all dietary expectations and fluid intake at the discretion of the Principal Investigator (PI).
- Female subjects must agree to use an acceptable form of birth control from screening through the duration of the study (unless otherwise stated). See section 5.1.1.
Who cannot join
- Subject has a history or presence of clinically significant cardiovascular, pulmonary, respiratory, digestive, hepatic, renal, hematological, gastrointestinal (e.g., active bowel disease, known gallstones, GERD, etc.), endocrine, metabolic, immunological, infectious, dermatologic, neurological, psychological, or psychiatric disease or gastrointestinal surgeries (e.g., bowel resection, gastric bypass, cholecystectomy within the 6 months prior to screening, etc.), in the opinion of the Principal Investigator.
- Subject has received a positive result for urine drug screen at the screening visit or on Day -3, or has a history of positive test result(s) for human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen or Hepatitis C antibody.
- Subject has a history of or a current clinically significant medical condition, allergy, food sensitivity (e.g. maltodextrin) or surgical intervention that might significantly compromise the safety of the subject, interfere with study assessments, or impact the validity of the study results, in the opinion of the Principal Investigator.
- Subject is taking a medication that would indicate significant anxiety, depression, serious or unstable illness, or lack of good general health, that could interfere with the subject's ability to adhere to study instructions, or complete the study, in the opinion of the Principal Investigator and with approval of the Sponsor.
- Subject is unable or unwilling to discontinue use of dietary supplements (vitamins, minerals, and/or supplements) throughout the duration of the study or has used these products within 7 days prior to screening.
- Subject has continuously used (not including intermittent or rare PRN use) prescription or over the counter: proton pump inhibitors within 12 weeks of screening; or H2 blockers within 6 weeks of screening; or antacids within 2 weeks of screening.
Show all 12Show fewer
- Subject is currently using medication that could affect oxalate handling such as cholestyramine, any carbonic anhydrase inhibitor, any steroid, any diuretic, any immunosuppressant drug, or has received chemotherapy or systemic immunosuppressive drugs within 6 mos. of their screening visit.
- Subject has had a clinically significant surgical procedure within 3 mos. prior to the Screening visit or planned surgical procedure during the study conduct.
- Subject has received an investigational product, device, or therapy within 30 days prior to screening.
- Subject has been on a self-restricted, controlled, or special therapeutic diet, or has had substantial changes in eating or bowel habits, or have had new GI complaints, within 30 days of their screening visit.
- Subject has been on systemic antibiotic therapy within 6 weeks prior to the screening visit or plans antibiotic therapy during the study conduct.
- Subject has a history of allergy or hypersensitivity to the study products, its excipients or any comparable products or excipients.
Trial locations and contacts
1 site in 1 country.
United States1 site
QPS Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802
About this study
Official title: A Prospective, Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study With Nephure™, an Orally Administered Oxalate Reducing Enzyme
The purpose of this double-blind study is to determine the effect of reducing oxalates in the diet of healthy volunteers by using Nephure, an oxalate-reducing enzyme, as compared to placebo.
Read the detailed description
This study aims at evaluating the effect from Nephure in reducing dietary oxalate in healthy volunteers on a controlled diet as compared to placebo. Subjects are on a normal diet with controlled oxalate (750mg/day) and calcium (550mg/day) levels for 8 consecutive days. The study is a cross-over design with two four-day treatment periods. The study intends to determine level of reduction in urinary oxalate output as a measure of the effect of Nephure on dietary oxalate when ingested with a meal.
- Conditions
- Healthy
- Being tested
- Nephure Oxalate-reducing Enzyme, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephure Oxalate-reducing EnzymeDietary supplement
3g of Nephure is mixed with 8oz of water and ingested with breakfast, lunch and dinner.
PlaceboOther
3g of non-GMO maltodextrin is mixed with 8oz of water and ingested with breakfast, lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3g of non-GMO maltodextrin Receives: Other: Placebo |
| Nephure | Active comparator | 3g of Nephure Receives: Dietary Supplement: Nephure Oxalate-reducing Enzyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Subject Urinary Oxalate Excretion
Milligram of oxalate per 24 hours is determined on dosing days. Within-subject difference in 24 hours urinary oxalate excretion between placebo and Nephure is determined.
Measured: 8 days
Between Groups Urinary Oxalate Excretion
Milligram of oxalate per 24 hours is determined on dosing days. Mean difference in 24 hours urinary oxalate excretion between placebo and Nephure groups is determined.
Measured: 8 days
Secondary outcomes (2)
Urinary Oxalate Excretion Compared to Baseline
Difference in 24 hours urinary oxalate excretion between dosing days and the baseline day immediately preceding is determined.
Measured: 8 days
Adverse Events
Number of participants with adverse events.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start11 Jul 2018
- Primary completion5 Aug 2018
- Study completion5 Aug 2018
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 HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized, placebo-controlled, cross-over study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Captozyme, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Donald Burkindine, D.O., QPS-Qualitix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661216
- Sponsor's protocol ID
- 95318
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cowley H, Yan Q, Koetzner L, Dolan L, Nordwald E, Cowley AB. In vitro and in vivo safety evaluation of Nephure. Regul Toxicol Pharmacol. 2017 Jun;86:241-252. doi: 10.1016/j.yrtph.2017.03.016. Epub 2017 Mar 18.
PubMed 28322893Quintero E, Bird VY, Liu H, Stevens G, Ryan AS, Buzzerd S, Klimberg IW. A Prospective, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Using an Orally Administered Oxalate Decarboxylase (OxDC). Kidney360. 2020 Sep 3;1(11):1284-1290. doi: 10.34067/KID.0001522020. eCollection 2020 Nov 25.
PubMed 35372879
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study With Nephure™, an Orally Administered Oxalate Reducing Enzyme
- ClinicalTrials.gov ID
- NCT03661216
- Acronym / sponsor ID
- 95318
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Captozyme, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 5 Aug 2018 (actual)
- First posted
- 7 Sep 2018 (actual)
- 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.
The purpose of this double-blind study is to determine the effect of reducing oxalates in the diet of healthy volunteers by using Nephure, an oxalate-reducing enzyme, as compared to placebo.
Detailed description
This study aims at evaluating the effect from Nephure in reducing dietary oxalate in healthy volunteers on a controlled diet as compared to placebo. Subjects are on a normal diet with controlled oxalate (750mg/day) and calcium (550mg/day) levels for 8 consecutive days. The study is a cross-over design with two four-day treatment periods. The study intends to determine level of reduction in urinary oxalate output as a measure of the effect of Nephure on dietary oxalate when ingested with a meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled, cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo3g of non-GMO maltodextrin |
| Nephure | Active comparator | Dietary Supplement: Nephure Oxalate-reducing Enzyme3g of Nephure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject has granted written informed consent.
- Subject must be a male or non-pregnant female, at least 18 to 55 years of age at the time of Screening, and non-smoker for at least 3 months at the time of screening and throughout study.
- Subject has a BMI of 18.5 - 29.9 kg/m2 at the time of Screening.
- Subject has an estimated glomerular filtration rate (eGFR) of >90 mL/min/1.73 m2 at the time of Screening (GFR is calculated using the NIDDK provided equation at the following web address: www.niddk.nih.gov/health-information/communication-programs/nkdep/laboratory-evaluation/glomerular-filtration-rate-calculators/ckd-epi-adults-conventional-units.)
- Subject has a urinary oxalate <40.5mg/24 hours at the time of Screening .
Key exclusion criteria (12 listed)
- Subject has a history or presence of clinically significant cardiovascular, pulmonary, respiratory, digestive, hepatic, renal, hematological, gastrointestinal (e.g., active bowel disease, known gallstones, GERD, etc.), endocrine, metabolic, immunological, infectious, dermatologic, neurological, psychological, or psychiatric disease or gastrointestinal surgeries (e.g., bowel resection, gastric bypass, cholecystectomy within the 6 months prior to screening, etc.), in the opinion of the Principal Investigator.
- Subject has received a positive result for urine drug screen at the screening visit or on Day -3, or has a history of positive test result(s) for human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen or Hepatitis C antibody.
- Subject has a history of or a current clinically significant medical condition, allergy, food sensitivity (e.g. maltodextrin) or surgical intervention that might significantly compromise the safety of the subject, interfere with study assessments, or impact the validity of the study results, in the opinion of the Principal Investigator.
- Subject is taking a medication that would indicate significant anxiety, depression, serious or unstable illness, or lack of good general health, that could interfere with the subject's ability to adhere to study instructions, or complete the study, in the opinion of the Principal Investigator and with approval of the Sponsor.
- Subject is unable or unwilling to discontinue use of dietary supplements (vitamins, minerals, and/or supplements) throughout the duration of the study or has used these products within 7 days prior to screening.
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 |
|---|---|---|
| Nephure Oxalate-reducing Enzyme3g of Nephure is mixed with 8oz of water and ingested with breakfast, lunch and dinner. | Dietary supplement | Nephure |
| Placebo3g of non-GMO maltodextrin is mixed with 8oz of water and ingested with breakfast, lunch and dinner. | Other | Placebo |
Primary outcome
Within-Subject Urinary Oxalate Excretion
Time frame: 8 days
Milligram of oxalate per 24 hours is determined on dosing days. Within-subject difference in 24 hours urinary oxalate excretion between placebo and Nephure is determined.
Between Groups Urinary Oxalate Excretion
Time frame: 8 days
Milligram of oxalate per 24 hours is determined on dosing days. Mean difference in 24 hours urinary oxalate excretion between placebo and Nephure groups is determined.
2 secondary outcomes
Urinary Oxalate Excretion Compared to Baseline
Time frame: 8 days
Adverse Events
Time frame: 8 days
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 19 Sep 2018.
- Background: PubMed 28322893Cowley H, Yan Q, Koetzner L, Dolan L, Nordwald E, Cowley AB. In vitro and in vivo safety evaluation of Nephure. Regul Toxicol Pharmacol. 2017 Jun;86:241-252. doi: 10.1016/j.yrtph.2017.03.016. Epub 2017 Mar 18.
- Derived from this study: PubMed 35372879Quintero E, Bird VY, Liu H, Stevens G, Ryan AS, Buzzerd S, Klimberg IW. A Prospective, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Using an Orally Administered Oxalate Decarboxylase (OxDC). Kidney360. 2020 Sep 3;1(11):1284-1290. doi: 10.34067/KID.0001522020. eCollection 2020 Nov 25.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nephure Oxalate-reducing Enzyme in people with Healthy, run by Captozyme, Inc. 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 10 inclusion and 12 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 19 Sep 2018. 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.
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?
Within-Subject Urinary Oxalate Excretion (time frame: 8 days). 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 NCT03661216, 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 19 Sep 2018.