## Protocol Section
### Identification Module
**NCT ID:** NCT06434961

**Brief Title:** The Trial of SHR6508 in Secondary Hyperparathyroidism

**Official Title:** A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

#### Organization Study ID Info
**ID:** SHR6508-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Hengrui Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shanghai Hengrui Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The study is being conducted to evaluate the efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.

### Conditions Module

**Conditions:**

- Secondary Hyperparathyroidism

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 486

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: SHR6508 plus oral placebo tablets

**Label:** Treatment group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Cinacalcet plus intravenous placebo

**Label:** Active Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment group

**Description:** SHR6508 plus oral placebo tablets

**Name:** SHR6508 plus oral placebo tablets

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Active Control group

**Description:** Cinacalcet plus intravenous placebo

**Name:** Cinacalcet plus intravenous placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** iPTH was tested at a central laboratory.

**Measure:** Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline

**Time Frame:** efficacy assessment period, defined as Week 20-27

#### Secondary Outcomes

**Description:** iPTH was tested at a central laboratory.

**Measure:** Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline

**Time Frame:** efficacy assessment period, defined as Week 20-27

**Description:** Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)

**Measure:** Incidence of nausea and vomiting events

**Time Frame:** Day1 to End of Treatment, End of Treatment is about Week 27

**Description:** iPTH was tested at a central laboratory.

**Measure:** Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline

**Time Frame:** efficacy assessment period, defined as Week 20-27

**Description:** cCa and P were tested at a central laboratory.

**Measure:** Change From Baseline in serum cCa and P

**Time Frame:** efficacy assessment period, defined as Week 20-27

**Description:** Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)

**Measure:** Participants With Treatment-Emergent Adverse Events (TEAEs)

**Time Frame:** Day1 to End of Study, End of Study is about Week 31

**Description:** Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.

**Measure:** Participants with Anti-SHR6508 Antibody at baseline and postbaseline

**Time Frame:** Day1 to End of Study, End of Study is about Week 31

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kunming.li@hengrui.com

**Name:** Kunming Li

**Phone:** 0518-82342973

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Name:** Xueqing Yu

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Guangdong Provincial People's Hospital

**State:** Guangdong

**Zip:** 510000

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010279

- Term: Parathyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Secondary

- ID: M10012

- Name: Hyperparathyroidism

- Relevance: HIGH

- As Found: Hyperparathyroidism

- ID: M10013

- Name: Hyperparathyroidism, Secondary

- Relevance: HIGH

- As Found: Secondary Hyperparathyroidism

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M13192

- Name: Parathyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000006961

- Term: Hyperparathyroidism

- ID: D000006962

- Term: Hyperparathyroidism, Secondary

### Intervention Browse Module - Ancestors

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000057966

- Term: Calcimimetic Agents

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M418

- Name: Cinacalcet

- Relevance: HIGH

- As Found: Solifenacin

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069449

- Term: Cinacalcet

### Misc Info Module

- Version Holder: 2024-05-31
