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New drug SHR6508 aims to tame hormone imbalance in dialysis patients

NCT ID NCT06434961

Disease control Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called SHR6508 in 498 adults on hemodialysis who have secondary hyperparathyroidism, a condition where the parathyroid glands make too much hormone. The drug is given during dialysis and was compared to an existing oral medication, cinacalcet. The goal was to see if SHR6508 can safely lower parathyroid hormone levels by at least 30%.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR6508 (a drug given intravenously during dialysis to lower parathyroid hormone levels)
What this could lead to
If successful, SHR6508 could offer a new treatment option for controlling secondary hyperparathyroidism in kidney dialysis patients, potentially with fewer side effects than current therapies.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove superior to existing treatments like cinacalcet, and side effects such as nausea and vomiting are possible.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

498 people

The number who actually took part.

Started

Jun 2024

Finished

Nov 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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Diagnosed with end stage renal disease receiving maintenance hemodialysis 3. Male or female 4. Meet the Body Mass Index standard 5. Stably use of concomitant medication of other therapies of SHPT 6. Meet the standard of iPTH level, cCa Exclusion Criteria: 1. Subjects with a history of malignant tumor 2. Subjects with neuropsychiatric diseases 3. Subjects with a history of cardiovascular diseases 4. Subjects with gastrointestinal diseases 5. Subjects with a history of surgery 6. Subjects with a history of blood loss 7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 8. Subjects with a treatment history of similar drugs 9. Allergic to a drug ingredient or component 10. Pregnant or nursing women 11. No birth control during the specified period of time 12. Subject with a history of alcohol abuse and drug abuse 13. Participated in clinical trials of other drugs 14. 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.

secondary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Secondary hyperparathyroidism

Contacts and locations

Locations

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.