Tiny study tracks kidney Drug's exit route in dialysis patients
NCT ID NCT06877247
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This completed Phase 1 study looked at how a radioactive form of the drug SHR6508 is processed and eliminated in 5 Chinese adults on hemodialysis who have secondary hyperparathyroidism. The main goal was to measure how much radioactivity ends up in urine and stool, and to identify the drug's breakdown products in the blood. This is a basic science study to understand the drug's journey through the body, not a test of whether it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [14C] SHR6508 Injection
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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5 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
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Oct 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be able and willing to provide a written informed consent form. 2. Male subjects and postmenopausal women. 3. Meet the Body Mass Index (BMI) standard. Exclusion Criteria: 1. Subjects with a history of cardiovascular diseases. 2. Subjects with gastrointestinal diseases. 3. Subjects with a history of surgery. 4. Subjects with a history of blood loss. 5. Abnormal blood pressure. 6. Be allergic to a drug ingredient or component. 7. Subject with a history of alcohol abuse and drug abuse 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, 250014, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dialysis drug showdown: which vitamin d works best?
- New blood test could end painful bone biopsies for kidney disease patients
- New blood test may reveal bone health in kids on dialysis
- New hope for kids with kidney disease: experimental vitamin d pill enters trial
- New drug SHR6508 aims to tame hormone imbalance in dialysis patients
- New drug aims to tame parathyroid glands in dialysis patients