Cancer PainRenal Insufficiency ChronicHydromorphone Use
Study 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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 65 years.
2. Pathologically or cytologically confirmed malignant tumor.
3. Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4).
4. Renal function meeting one of the following criteria at baseline:
1）Mild-to-moderate renal insufficiency group: 30 mL/min/1.73m² ≤ estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m².
2）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.
Exclusion Criteria:
1. Severe renal insufficiency (eGFR \< 30 mL/min/1.73m²) or requirement for renal replacement therapy.
2. Severe hepatic insufficiency (alanine aminotransferase / aspartate aminotransferase ≥ 2.5 times the upper limit of normal or Child-Pugh Class C).
3. Paralytic ileus.
4. Pain of unclear origin or pain that is solely acute/incident pain.
5. Symptoms or history of diseases such as intracranial hypertension, head injury, cerebral aneurysm, or other central nervous system disorders.
6. Symptoms of prostatic hypertrophy, thyroid dysfunction, or urethral stricture. Symptoms of asthma, respiratory obstruction, or respiratory failure.
7. Known allergy or hypersensitivity to hydromorphone or oxycodone.
8. Use of monoamine oxidase inhibitors within 14 days prior to enrollment.
9. Participation in any other clinical trial within 1 month prior to enrollment.
10. Any other condition considered by the investigator as unsuitable for participation in this study.
Primary outcome measure(s)
The changes in estimated glomerular filtration rate (eGFR) from baseline at the end of the 4th week of treatmentDetailed — From the start of maintenance treatment with hydromorphinone sustained-release tablets until the end of the fourth week of treatment. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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