A Phase 4 interventional study of Sucroferric Oxyhydroxide Chewable Tablet in Peritoneal Dialysis Complication, Hyperphosphatemia and Hypoalbuminemia, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Treatment
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Among 56 studies in Hyperphosphatemia with a site in United States — 4 open to participants now, 4 under way, 1 of them phase 3. Hyperphosphatemia · United States.
Among the 56 studies in Hyperphosphatemia with a site in United States, this one is the 47th largest by enrollment of the 52 interventional ones that give a count, is one of 3 that started in 2020, is one of 10 in phase 4, and was the 48th registered.
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
Browse Hyperphosphatemia studies →4 of the 56 studies in Hyperphosphatemia with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 18+
R1 Therapeutics · Sites in United States, China
Ages 18+
Alebund Pharmaceuticals · Sites in United States, China
Ages 12+
Duke University · Sites in United States, Canada
Ages 0–20 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Hyperphosphatemia studies recruiting now, 11 (85%) set no upper age limit and 2 (15%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
56 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 13 · Phase 3 18 · Phase 4 10
First in 2005; this study’s year is marked. 3 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.
Median enrollment 114 across the 52 interventional studies, 1,070 across the 4 observational. Of the 47 that completed or were terminated, 25 (53%) have results posted.
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34 of 56 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study filed under Hyperphosphatemia — fewer than ten, so there is no comparison to draw.
2 of the studies in Hyperphosphatemia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT06712654R1 TherapeuticsA Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia | 2027-02-28 |
Add all 2 to your calendar (.ics) → With an account.
Among the 56 studies in Hyperphosphatemia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.
Drug: Sucroferric Oxyhydroxide Chewable Tablet
Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Serum Phosphate at Baseline
Serum phosphate at baseline
Time frame: Baseline
Serum Phosphate at 6 Months
Serum phosphate at end of study (6 months)
Time frame: 6 months
Serum Albumin
Changes in serum albumin from baseline to 6 months
Time frame: Baseline, 6 months
Serum FGF23
Change in serum FGF23 from baseline to 6 months
Time frame: 6 months
Serum PTH
Change in serum PTH (perathyroid hormone) from baseline to 6 months
Time frame: Baseline, 6 months
Serum Prealbumin
Change in prealbumin from baseline to 6 months
Time frame: 6 months
| Milestone | Sucroferric Oxyhydroxide |
|---|---|
| Started | 17 |
| Completed | 12 |
| Not completed | 5 |
Serum phosphate at baseline
| mg/dL | Intervention |
|---|---|
| Serum Phosphate at Baseline | 7.47 ± 1.76 |
Serum phosphate at end of study (6 months)
| mg/dL | Intervention |
|---|---|
| Serum Phosphate at 6 Months | 5.69 ± 1.17 |
Changes in serum albumin from baseline to 6 months
| g/dL | Intervention |
|---|---|
| Baseline | 3.49 ± 0.37 |
| 6 Months | 3.50 ± 0.27 |
Change in serum FGF23 from baseline to 6 months
No measurements were reported for this outcome.
Change in serum PTH (perathyroid hormone) from baseline to 6 months
| picograms/mL | Intervention |
|---|---|
| Baseline | 416 (292 to 631) |
| 6 Months | 361 (237 to 540) |
Change in prealbumin from baseline to 6 months
No measurements were reported for this outcome.
Collected over Up to 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 2/17 (11.8%) | 2/17 (11.8%) | 9/17 (52.9%) |
| Event | Intervention |
|---|---|
| DeathCardiac disorders | 2/17 |
| Event | Intervention |
|---|---|
| GI symptomsGastrointestinal disorders | 9/17 |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 55 ± 14 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 6 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Intervention |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Intervention |
|---|---|
| United States | 17 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — At the end of the study deidentified data will be available to other researchers
Supporting information: Study protocol, Analytic code
Time frame: Data will be available at the completion of the study. Researchers must obtain PI approval
Ran from Feb 2020 to primary completion in Jul 2021, 17 months.
Results were first posted in Aug 2022, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
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University of Colorado, Denver →