Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency

NCT07421674 | Not Yet Recruiting DMC

• 2 other identifiers: 2025022YXH2025JS126
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to understand whether domestic hydromorphinone sustained-release tablets are effective and safe in treating moderate to severe cancer pain in elderly patients with renal insufficiency. It will also understand key safety concerns, especially regarding renal function and neurotoxicity. The main questions it aims to answer include:1. Can hydromorphinone sustained-release tablets effectively relieve the pain of such patients and improve their quality of life?2. During the treatment period, what effect does this drug have on renal function (measured by eGFR)? 3. In this specific population, what are the occurrence and characteristics of neurotoxicity and other side effects induced by opioids? Researchers will compare elderly cancer pain patients with renal insufficiency with those with normal renal function (both receiving the study drug treatment) to observe whether there are differences in efficacy and safety results. Participants will: Receive a standardized treatment plan: First, subcutaneous injection of hydromorphinone injection for dose titration, and then switch to daily oral administration of hydromorphinone sustained-release tablets for 4 weeks. Visit the clinic for assessment and examination (including renal function tests) during the baseline period, on the 7th day, and at the weekends of the 2nd, 3rd, and 4th days. Regularly monitor and record the degree of pain, the occurrence of explosive pain, the use of medication, and any side effects.

Conditions

Cancer Pain; Renal Insufficiency Chronic; Hydromorphone Use

Keywords

Cancer Pain; Renal Insufficiency; Aged; Hydromorphone; Opioid-Induced Neurotoxicity

Outcome Measures

Primary Outcomes (1)

• The changes in estimated glomerular filtration rate (eGFR) from baseline at the end of the 4th week of treatmentDetailed

  The estimated glomerular filtration rate (eGFR) is a validated indicator of kidney function. It is calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, which incorporates the patient's age and sex. All values are normalized to body surface area and expressed as mL/min/1.73m². On this scale, higher eGFR values indicate better kidney function, while lower values indicate impaired kidney function. The change in eGFR is defined as the value measured at week 4 minus the value measured at baseline (immediately prior to treatment initiation). A negative change value indicates a decrease in eGFR from baseline, representing a decline in kidney function. A positive change value indicates an increase in eGFR from baseline, representing an improvement in kidney function. eGFR is measured from venous blood samples collected at baseline and at week 4.

  From the start of maintenance treatment with hydromorphinone sustained-release tablets until the end of the fourth week of treatment.

Study Arms (2)

Hydromorphone - Renal Insufficiency Group

Elder cancer pain patients with mild to moderate renal insufficiency at enrollment, defined by an estimated glomerular filtration rate (eGFR) range of 30 ≤ eGFR \< 90 mL/min/1.73m². They receive standardized Hydromorphone Sustained-Release Tablet treatment.

Hydromorphone - Normal Renal Function Group

Elder cancer pain patients with normal renal function at enrollment, defined by an estimated glomerular filtration rate (eGFR) of eGFR ≥ 90 mL/min/1.73m². They receive the identical standardized Hydromorphone Sustained-Release Tablet treatment as Cohort 1, serving as the reference comparison group.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from the patient population presenting at the Oncology Department of Taian City Tumor Hospital, a regional tertiary cancer care center in Shandong Province, China. Recruitment will specifically target older adult patients with cancer who are being evaluated for and initiate standardized opioid therapy for moderate-to-severe cancer pain at this institution.

You may qualify if:

• Age ≥ 65 years.
• Pathologically or cytologically confirmed malignant tumor.
• Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4).
• Renal function meeting one of the following criteria at baseline:
• ）Mild-to-moderate renal insufficiency group: 30 mL/min/1.73m² ≤ estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m².
• ）Normal renal function group: eGFR ≥ 90 mL/min/1.73m². 5.Expected survival period ≥ 3 months. 6.Ability to take oral medication and cooperate with study assessments. 7.Willing to participate voluntarily and able to provide signed informed consent.

You may not qualify if:

• Severe renal insufficiency (eGFR \< 30 mL/min/1.73m²) or requirement for renal replacement therapy.
• Severe hepatic insufficiency (alanine aminotransferase / aspartate aminotransferase ≥ 2.5 times the upper limit of normal or Child-Pugh Class C).
• Paralytic ileus.
• Pain of unclear origin or pain that is solely acute/incident pain.
• Symptoms or history of diseases such as intracranial hypertension, head injury, cerebral aneurysm, or other central nervous system disorders.
• Symptoms of prostatic hypertrophy, thyroid dysfunction, or urethral stricture. Symptoms of asthma, respiratory obstruction, or respiratory failure.
• Known allergy or hypersensitivity to hydromorphone or oxycodone.
• Use of monoamine oxidase inhibitors within 14 days prior to enrollment.
• Participation in any other clinical trial within 1 month prior to enrollment.
• Any other condition considered by the investigator as unsuitable for participation in this study.

Sponsors & Collaborators

• Taian Cancer Hospital: lead

Study Sites (1)

Tai'an Caner Hospital

Tai’an, Shandong, 271000, China

Location

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MeSH Terms

Conditions

Cancer Pain; Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Central Study Contacts

Xian'guo Wang

CONTACT

+8613562898761; wangxianguo1111@163.com

Junjun Hou

CONTACT

+8613583834178

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 19, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start Date ：12 months after the publication of the primary study results in a peer-reviewed journal. End Date : 5 years after the IPD sharing start date.

Locations

CN (1)