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New injection aims to tame hormone chaos in kidney dialysis patients

NCT ID NCT06236295

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new drug called SHR6508 in 303 adults on hemodialysis who have secondary hyperparathyroidism, a condition where parathyroid hormone levels get too high. The drug is given as an injection to help control these hormone levels and related minerals like calcium and phosphorus. The main goal is to check the drug's safety and how well it works over the long term.

What this could mean

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

Active substance
SHR6508 injection
What this could lead to
If successful, this could provide a new treatment option to better manage secondary hyperparathyroidism in people on dialysis, potentially reducing bone and heart problems.
What could go wrong
This is a Phase 2 trial with no placebo group, so results are preliminary. The drug may cause side effects or not work better than existing treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

303 people

The number who actually took part.

Started

Feb 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. Subject is 18 years of age or older 2. Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent. 3. Subject must be receiving regular hemodialysis for at least 12 weeks 4. BMI ≥18 kg/m2 and ≤35 kg/m2 5. iPTH≥ 300pg/ mL Exclusion Criteria: 1. Subject has received a a history of malignant tumor within 5 years prior to screening 2. Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening. 3. Postdialysis systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg 4. Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients 5. Subject has a history of drug use or excessive alcohol use within 6 months prior to screening 6. Female subjects who were pregnant or lactating 7. Other reasons for not participating as deemed by the investigator

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Conditions

The condition(s) this trial relates to.

chronic kidney disease secondary hyperparathyroidism secondary hyperparathyroidism of renal origin

As listed by the trial registrant

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

Secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

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