End Stage Renal DiseaseNCT03594539
Phosphate Microvascular Study
A study testing Withholding standard phosphate binder in people with End Stage Renal Disease and Hyperphosphatemia, run by Veterans Medical Research Foundation.
Trial summary
Elevated phosphate concentrations in the blood have been associated with multiple negative health outcomes in patients with chronic kidney disease as well as in the general population. These negative outcomes include an increased risk of vascular complications like heart attack and stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Renal Disease, Hyperphosphatemia
- What is being tested?
- Withholding standard phosphate binder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 17 Jul 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ESRD on hemodialysis (HD) for >90 days.
- Age >21.
- Capacity to understand and sign informed consent as assess by principal investigator.
- On a phosphate binder with stable dose for >2 weeks.
- Serum phosphate at screening visit of <7.0.
Who cannot join
- Pregnancy.
- Actively breastfeeding.
- Use of oral contraceptives.
- Inability to take oral medications.
- History of medication non-compliance as assessed by the treating physician.
- Patients currently enrolled in another trial.
Show all 14Show fewer
- Planned or expected surgical procedure during study period.
- Planned or expected hospitalization during study period.
- Corrected serum calcium greater than 10.2 mg/dl.
- Serum intact PTH >1000 pg/ml
- Albumin < 3 g/dl.
- Allergy or intolerance to lanthanum carbonate.
- Principal investigator deems patient to be unsuitable.
- Non-English speaking persons. (Study performed at VA, therefore do not anticipate this represents a significant portion of the population).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Phosphate on Microvascular Function
Elevated phosphate concentrations in the blood have been associated with multiple negative health outcomes in patients with chronic kidney disease as well as in the general population. These negative outcomes include an increased risk of vascular complications like heart attack and stroke. While complications like heart attack and stroke reflect obstructive disease in large blood vessels, recent evidence suggests that elevated phosphate concentrations may first lead to disease in small blood vessels.
This single site clinical trial will randomize 20 veterans with end stage renal disease on hemodialysis to either a phosphate binder or placebo and evaluated for changes in their microvascular function using laser-Doppler flowmtery and nail-fold capillaroscopy.
Read the detailed description
Project Background: Recent studies have suggested that increased serum phosphate and phosphate intake may acute impair microvascular blood flow. However, this has never been directly tested using imaging techniques that directly measure microvascular flow. The end-stage renal disease population on hemodialysis at the VA San Diego is an ideal population to evaluate this effect.
Project Question: Does reduction of serum phosphate through the use of a phosphate binder (lanthanum carbonate) increase microvascular blood flow in persons with ESRD? Project Methods: The investigators propose a 4 week, randomized, double-blinded, placebo controlled, single-center, crossover trial. Participants will have their microvascular function assessed at the baseline of the study using laser-Doppler flowmetry and nail-fold capillaroscopy. They will then be randomized to either lanthanum carbonate or placebo for 2 weeks. Microvascular measurements will be repeated at the end of the 2 week period. Participants will then cross-over to the other study arm. After 2 weeks in the other study arm, they will have microvascular measurements repeated and the trial will then be complete. The primary outcome of the study will be the % change in skin blood flow after heating from 31 degrees Celsius to 44 degrees Celsius. This will be compared within each individual after they complete each arm of the study. Changes seen on nail-fold capillaroscopy, acceptability, safety, and adherence will be key secondary outcomes.
- Conditions
- End Stage Renal Disease, Hyperphosphatemia
- Being tested
- Withholding standard phosphate binder
- Keywords
- ESRD, Microvascular, Hyperphosphatemia, LDF
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withholding standard phosphate binderOther
In this trial, placebo represents the intervention and not the control. Standard therapy for hyperphosphatemia in end-stage renal disease includes treatment with a phosphate binder. In this trial the intervention will be to withhold the phosphate binder and use placebo instead. In this way the effect of a higher serum phosphate can be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Participants will have their hyperphosphatemia managed with lanthanum carbonate 1 g with meals and 500 mg with snacks as per typical care, for 2 weeks. |
| Intervention | Placebo comparator | Participants will take a placebo instead of standard care with a phosphate binder, for 2 weeks. Receives: Other: Withholding standard phosphate binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change in flux of blood after skin heating to 44 C as measured using laser-Doppler flowmtery.
Flux of blood through skin will be measured using a Perimed PF5000. This will be performed at baseline in a temperature controlled room. Baseline skin measurements will be made at 31C. Skin will then be heated to 44 C. The percent change will be the outcome. This outcome will be compared within each person at the conclusion of each arm. Measurements will all be made on the Monday or Tuesday, the day of the participant's first dialysis treatment of the week. Measurements will be made prior to dialysis.
Measured: Performed at initial study visit, at the end of the first arm of the study (Day 14) and again at the end of the second arm of the study (Day 28)
Secondary outcomes (1)
Change in capillary count seen post occlusion from pre occlusion, as determined by nail-fold capillaroscopy.
Participants will undergo nail fold capillaroscopy using a CapiScope (KK Technology, Honiton United Kingdom) at baseline and then at the end of each treatment arm. Using a capillarascope a capillary count will be made. After measurement a BP cuff will be inflated to 200 mm Hg occlude flow to a single digit for 1 minute. 30 sec after release the count will be made again. This change will be compared within individuals between measurements made at the completion of each arm in the study. Measurements will all be made on the Monday or Tuesday, the day of the participant's first dialysis treatment of the week. Measurements will be made prior to dialysis. Values at the end of each treatment arm will be compared.
Measured: Performed at initial study visit, at the end of the first arm of the study (Day 14) and again at the end of the second arm of the study (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion17 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to either lanthanum carbonate or placebo for 2 weeks. They will then be assigned to the other arm of the study. They will be in the alternate arm for 2 weeks and then complete the study,
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego Veterans Healthcare System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594539
- Sponsor's protocol ID
- VAH170095
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data may be shared at end of study
Publications
O'Seaghdha CM, Hwang SJ, Muntner P, Melamed ML, Fox CS. Serum phosphorus predicts incident chronic kidney disease and end-stage renal disease. Nephrol Dial Transplant. 2011 Sep;26(9):2885-90. doi: 10.1093/ndt/gfq808. Epub 2011 Feb 3.
PubMed 21292817Thambyrajah J, Landray MJ, McGlynn FJ, Jones HJ, Wheeler DC, Townend JN. Abnormalities of endothelial function in patients with predialysis renal failure. Heart. 2000 Feb;83(2):205-9. doi: 10.1136/heart.83.2.205.
PubMed 10648498Stevens KK, Denby L, Patel RK, Mark PB, Kettlewell S, Smith GL, Clancy MJ, Delles C, Jardine AG. Deleterious effects of phosphate on vascular and endothelial function via disruption to the nitric oxide pathway. Nephrol Dial Transplant. 2017 Oct 1;32(10):1617-1627. doi: 10.1093/ndt/gfw252.
PubMed 27448672
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Phosphate on Microvascular Function
- ClinicalTrials.gov ID
- NCT03594539
- Acronym / sponsor ID
- VAH170095
- Conditions
- End Stage Renal Disease, Hyperphosphatemia
- Keywords
- ESRD, Microvascular, Hyperphosphatemia, LDF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- San Diego Veterans Healthcare System
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 17 Jul 2021 (estimated)
- First posted
- 20 Jul 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.
Elevated phosphate concentrations in the blood have been associated with multiple negative health outcomes in patients with chronic kidney disease as well as in the general population. These negative outcomes include an increased risk of vascular complications like heart attack and stroke. While complications like heart attack and stroke reflect obstructive disease in large blood vessels, recent evidence suggests that elevated phosphate concentrations may first lead to disease in small blood vessels.
This single site clinical trial will randomize 20 veterans with end stage renal disease on hemodialysis to either a phosphate binder or placebo and evaluated for changes in their microvascular function using laser-Doppler flowmtery and nail-fold capillaroscopy.
Detailed description
Project Background: Recent studies have suggested that increased serum phosphate and phosphate intake may acute impair microvascular blood flow. However, this has never been directly tested using imaging techniques that directly measure microvascular flow. The end-stage renal disease population on hemodialysis at the VA San Diego is an ideal population to evaluate this effect.
Project Question: Does reduction of serum phosphate through the use of a phosphate binder (lanthanum carbonate) increase microvascular blood flow in persons with ESRD? Project Methods: The investigators propose a 4 week, randomized, double-blinded, placebo controlled, single-center, crossover trial. Participants will have their microvascular function assessed at the baseline of the study using laser-Doppler flowmetry and nail-fold capillaroscopy. They will then be randomized to either lanthanum carbonate or placebo for 2 weeks. Microvascular measurements will be repeated at the end of the 2 week period. Participants will then cross-over to the other study arm. After 2 weeks in the other study arm, they will have microvascular measurements repeated and the trial will then be complete. The primary outcome of the study will be the % change in skin blood flow after heating from 31 degrees Celsius to 44 degrees Celsius. This will be compared within each individual after they complete each arm of the study. Changes seen on nail-fold capillaroscopy, acceptability, safety, and adherence will be key secondary outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either lanthanum carbonate or placebo for 2 weeks. They will then be assigned to the other arm of the study. They will be in the alternate arm for 2 weeks and then complete the study,
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Participants will have their hyperphosphatemia managed with lanthanum carbonate 1 g with meals and 500 mg with snacks as per typical care, for 2 weeks. |
| Intervention | Placebo comparator | Other: Withholding standard phosphate binderParticipants will take a placebo instead of standard care with a phosphate binder, for 2 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of ESRD on hemodialysis (HD) for >90 days.
- Age >21.
- Capacity to understand and sign informed consent as assess by principal investigator.
- On a phosphate binder with stable dose for >2 weeks.
- Serum phosphate at screening visit of <7.0.
Key exclusion criteria (14 listed)
- Pregnancy.
- Actively breastfeeding.
- Use of oral contraceptives.
- Inability to take oral medications.
- History of medication non-compliance as assessed by the treating physician.
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 |
|---|---|---|
| Withholding standard phosphate binderIn this trial, placebo represents the intervention and not the control. Standard therapy for hyperphosphatemia in end-stage renal disease includes treatment with a phosphate binder. In this trial the intervention will be to withhold the phosphate binder and use placebo instead. In this way the effect of a higher serum phosphate can be evaluated. | Other | Intervention |
Primary outcome
% Change in flux of blood after skin heating to 44 C as measured using laser-Doppler flowmtery.
Time frame: Performed at initial study visit, at the end of the first arm of the study (Day 14) and again at the end of the second arm of the study (Day 28)
Flux of blood through skin will be measured using a Perimed PF5000. This will be performed at baseline in a temperature controlled room. Baseline skin measurements will be made at 31C. Skin will then be heated to 44 C. The percent change will be the outcome. This outcome will be compared within each person at the conclusion of each arm. Measurements will all be made on the Monday or Tuesday, the day of the participant's first dialysis treatment of the week. Measurements will be made prior to dialysis.
1 secondary outcome
Change in capillary count seen post occlusion from pre occlusion, as determined by nail-fold capillaroscopy.
Time frame: Performed at initial study visit, at the end of the first arm of the study (Day 14) and again at the end of the second arm of the study (Day 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Background: PubMed 21292817O'Seaghdha CM, Hwang SJ, Muntner P, Melamed ML, Fox CS. Serum phosphorus predicts incident chronic kidney disease and end-stage renal disease. Nephrol Dial Transplant. 2011 Sep;26(9):2885-90. doi: 10.1093/ndt/gfq808. Epub 2011 Feb 3.
- Background: PubMed 10648498Thambyrajah J, Landray MJ, McGlynn FJ, Jones HJ, Wheeler DC, Townend JN. Abnormalities of endothelial function in patients with predialysis renal failure. Heart. 2000 Feb;83(2):205-9. doi: 10.1136/heart.83.2.205.
- Background: PubMed 27448672Stevens KK, Denby L, Patel RK, Mark PB, Kettlewell S, Smith GL, Clancy MJ, Delles C, Jardine AG. Deleterious effects of phosphate on vascular and endothelial function via disruption to the nitric oxide pathway. Nephrol Dial Transplant. 2017 Oct 1;32(10):1617-1627. doi: 10.1093/ndt/gfw252.
- Individual participant dataSharing planned: Yes. de-identified data may be shared at end of study
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Withholding standard phosphate binder in people with End Stage Renal Disease and Hyperphosphatemia, run by Veterans Medical Research Foundation.
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 14 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Ginsberg, MD (8585528585 ext. 2243, cginsberg@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Change in flux of blood after skin heating to 44 C as measured using laser-Doppler flowmtery. (time frame: Performed at initial study visit, at the end of the first arm of the study (Day 14) and again at the end of the second arm of the study (Day 28)). 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 NCT03594539, which also lists 3 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 24 Aug 2018.