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Multicenter prospective observational study of the effects of calcitriol/parietal treatment on inflammatory status and anemia in Hemodialysis patients with SHPT in China

Multicenter prospective observational study of the effects of calcitriol/parietal treatment on inflammatory status and anemia in Hemodialysis patients with SHPT in China

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056404
Enrollment
Unknown
Registered
2022-02-05
Start date
2021-10-08
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

secondary hyperparathyroidism

Interventions

Oral calcitol group:Oral calcitol
I.v. Paricalcitol group:I.v. Paricalcitol

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. CKD stage 5 and maintenance dialysis for at least 3 months, 3 times a week, Kt/V > 1.2; 2. Initial treatment: Never received active VD and analogues; 3. Treated patients: were receiving active VD and analogues and iPTH levels continued to be higher than 300pg/ml, or showed a continuous upward trend in the past 3 tests; 4. Aged over 18 years; 5. Baseline blood calcium was less than 10.0mg/dL(2.5mmol/L).

Exclusion criteria

Exclusion criteria: 1.The patient's serum iPTH level continued to exceed 1500pg/ml on two consecutive tests recently; 2.The patient had an allergic reaction to active VD and its analogues; 3.Patients who underwent parathyroidectomy within 1 year; 4.Patients meeting the indications for parathyroidectomy; 5.SHPT is severe and the patient is resistant to active VD and its analogues; 6.Persistent hypercalcium and/or hyperphosphatemia that fails to respond to medical treatment; 7.There is at least one radiographic evidence of an enlarged parathyroid gland, such as an enlarged parathyroid gland with a diameter of > 1cm and abundant blood flow on high-frequency color ultrasound; 8.Severe infection; 9.Concomitant malignant tumor; 10.Patients with a history of alcohol or drug abuse in the past 6 months; 11.Pregnancy; 12.Complicated with severe liver disease or liver insufficiency; 13.Allergy or intolerance to any therapeutic drug; 14.Patients were still participating in other drug/device clinical studies 4 weeks prior to enrollment; 15.The inestigators considered the patients unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Inflammatory factor levels;Hemoglobin level;

Secondary

MeasureTime frame
Biochemical indicators related to secondary hyperparathyroidism (PTH, Ca, P, and alkaline phosphatase levels and their changes from baseline);Valve calcification;Life Function Scale;

Countries

China

Contacts

Public ContactLu Chen

The First Affiliated Hospital of Xinjiang Medical University

zhanglily1030@163.com+86 15999172037

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026