Chronic Kidney Disease Mineral and Bone DisorderNCT03108222
Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease
An observational study of Chronic Kidney Disease Mineral and Bone Disorder, run by Purdue University at 1 site in United States.
Trial summary
Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney function are primary driving forces behind cardiovascular dysfunction and mortality in CKD… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease Mineral and Bone Disorder
- What is being tested?
- Phosphorus Absorption Test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to Dec 2019
- Phase
- Observational
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and subjects with moderate CKD will be recruited from the community.
Who may be able to join
- Men and women ages 30-75 years old, any race
- Moderate CKD, based on the last set of labs done in the past year, defined as:
- Glomerular Filtration Rate (GFR) category G3a (eGFR 45-59 mL/min) with A2 or A3 albuminuria or proteinuria by positive dipstick or urine protein/creatinine ratio (UPCR); -or- G3b (eGFR 30-44 mL/min), with or without evidence of albuminuria (any A1-A3) or proteinuria. (Figure 1)
- -or- Healthy control with no diagnosis or evidence of CKD
- Female subjects must be post-menopausal, surgically sterile, or confirmed not pregnant by pregnancy test and not breastfeeding.
- Subjects must be on stable doses of medications (except those noted in exclusion criteria) for at least 6 weeks prior to the study
Who cannot join
- Plans to initiate dialysis within 6 months
- Labs based on the last set done in the past year:
- Hypercalcemia defined as serum calcium > 10.5 mg/dL
- Hyperkalemic > 5.5 mg/dL Prescribed a phosphate binder medication
- Small bowel resection, bariatric surgery. Medically unstable or poorly controlled hypertension, diabetes, or gastrointestinal disorders in the opinion of the physicians on the study team
- Calcitriol, ergocalciferol, cholecalciferol, vitamin D analogs, calcimimetics, PTH analogues, calcium supplements, multivitamins/mineral and other medications that may alter phosphorus metabolism - must be off for at least 6 weeks prior to study
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University Nutrition Science Department
West Lafayette, Indiana, 47907
About this study
Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney function are primary driving forces behind cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an critical aspect in P homeostasis but has been understudied, particularly in the early stages of CKD progression. This study aims to determine P absorption in patients with moderate CKD compared to healthy adults.
- Being tested
- Phosphorus Absorption Test
- Keywords
- chronic kidney disease, CKD, renal failure, phosphorus, phosphate, intestinal absorption
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphorus Absorption TestOther
Subjects will undergo a radiophosphorus (P-33) absorption test over two days, that will include an oral administration of P-33 on the 1st day of the test, and an IV administration of P-33 on the 2nd day of the test. P-33 activity from serial serum and urine collections will be determined by scintillation counting, and fractional phosphorus absorption calculated by kinetic modeling.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Healthy subjects, free of CKD Receives: Other: Phosphorus Absorption Test | |
| Moderate CKD Subjects | Subjects with moderate-stage CKD Receives: Other: Phosphorus Absorption Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Phosphorus Absorption
Radiophosphorus (P-33) activity determined by liquid scintillation counting in serum and urine after oral and IV administration will be used to determine fractional phosphate absorption.
Measured: Measured from serial blood draws over a 4-hour time frame
Secondary outcomes (5)
Serum FGF23
serum intact and c-terminal FGF23
Measured: Measured from baseline measures and serial blood draws over a 4-hour time frame
Serum 1,25(OH)2D
serum 1,25-dihydroxyvitamin D
Measured: Measured from baseline measures and serial blood draws over a 4-hour time frame
Serum parathyroid hormone (PTH)
serum intact parathyroid hormone
Measured: Measured from baseline measures and serial blood draws over a 4-hour time frame
Serum phosphate
serum phosphate
Measured: Measured from baseline measures and serial blood draws over a 4-hour time frame
24h Urine phosphate
24h urine phosphate
Measured: measured from two, 24-hour urine collections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start25 Apr 2018
- Primary completion30 Aug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Mineral and Bone DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Hill Gallant, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108222
- Sponsor's protocol ID
- 1612460566
- Status last verified
- Jul 2019
- First submitted
- 5 Apr 2017
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stremke ER, Wiese GN, Moe SM, Wastney ME, Moorthi RN, Hill Gallant KM. Intestinal Phosphorus Absorption in Moderate CKD and Healthy Adults Determined Using a Radioisotopic Tracer. J Am Soc Nephrol. 2021 Aug;32(8):2057-2069. doi: 10.1681/ASN.2020091340. Epub 2021 Jul 8.
PubMed 34244325
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03108222
- Acronym / sponsor ID
- 1612460566
- Keywords
- chronic kidney disease, CKD, renal failure, phosphorus, phosphate, intestinal absorption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Apr 2017 (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.
Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney function are primary driving forces behind cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an critical aspect in P homeostasis but has been understudied, particularly in the early stages of CKD progression. This study aims to determine P absorption in patients with moderate CKD compared to healthy adults.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Other: Phosphorus Absorption TestHealthy subjects, free of CKD |
| Moderate CKD Subjects | – | Other: Phosphorus Absorption TestSubjects with moderate-stage CKD |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and subjects with moderate CKD will be recruited from the community.
Key inclusion criteria (6 listed)
- Men and women ages 30-75 years old, any race
- Glomerular Filtration Rate (GFR) category G3a (eGFR 45-59 mL/min) with A2 or A3 albuminuria or proteinuria by positive dipstick or urine protein/creatinine ratio (UPCR); -or- G3b (eGFR 30-44 mL/min), with or without evidence of albuminuria (any A1-A3) or proteinuria. (Figure 1)
- -or- Healthy control with no diagnosis or evidence of CKD
- Female subjects must be post-menopausal, surgically sterile, or confirmed not pregnant by pregnancy test and not breastfeeding.
- Subjects must be on stable doses of medications (except those noted in exclusion criteria) for at least 6 weeks prior to the study
Key exclusion criteria (6 listed)
- Plans to initiate dialysis within 6 months
- Hypercalcemia defined as serum calcium > 10.5 mg/dL
- Hyperkalemic > 5.5 mg/dL Prescribed a phosphate binder medication
- Small bowel resection, bariatric surgery. Medically unstable or poorly controlled hypertension, diabetes, or gastrointestinal disorders in the opinion of the physicians on the study team
- Calcitriol, ergocalciferol, cholecalciferol, vitamin D analogs, calcimimetics, PTH analogues, calcium supplements, multivitamins/mineral and other medications that may alter phosphorus metabolism - must be off for at least 6 weeks prior to study
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 |
|---|---|---|
| Phosphorus Absorption TestSubjects will undergo a radiophosphorus (P-33) absorption test over two days, that will include an oral administration of P-33 on the 1st day of the test, and an IV administration of P-33 on the 2nd day of the test. P-33 activity from serial serum and urine collections will be determined by scintillation counting, and fractional phosphorus absorption calculated by kinetic modeling. | Other | Healthy Subjects, Moderate CKD Subjects |
Primary outcome
Fractional Phosphorus Absorption
Time frame: Measured from serial blood draws over a 4-hour time frame
Radiophosphorus (P-33) activity determined by liquid scintillation counting in serum and urine after oral and IV administration will be used to determine fractional phosphate absorption.
5 secondary outcomes
Serum FGF23
Time frame: Measured from baseline measures and serial blood draws over a 4-hour time frame
Serum 1,25(OH)2D
Time frame: Measured from baseline measures and serial blood draws over a 4-hour time frame
Serum parathyroid hormone (PTH)
Time frame: Measured from baseline measures and serial blood draws over a 4-hour time frame
Serum phosphate
Time frame: Measured from baseline measures and serial blood draws over a 4-hour time frame
24h Urine phosphate
Time frame: measured from two, 24-hour urine collections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Derived from this study: PubMed 34244325Stremke ER, Wiese GN, Moe SM, Wastney ME, Moorthi RN, Hill Gallant KM. Intestinal Phosphorus Absorption in Moderate CKD and Healthy Adults Determined Using a Radioisotopic Tracer. J Am Soc Nephrol. 2021 Aug;32(8):2057-2069. doi: 10.1681/ASN.2020091340. Epub 2021 Jul 8.
- 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.
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?
An observational study of Chronic Kidney Disease Mineral and Bone Disorder, run by Purdue University 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. 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. 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?
Results are not available in the source record.
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?
Fractional Phosphorus Absorption (time frame: Measured from serial blood draws over a 4-hour time frame). 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 NCT03108222, 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 10 Jul 2019.