Evidence map›Paper›PMID 40290446›Full record

ArticleFrontiers in pharmacology2025

Efficacy and safety of intermittent intravenous doxercalciferol in the treatment of secondary hyperparathyroidism in Chinese patients on maintenance hemodialysis: a phase II, open-label, prospective, multicenter study.

Guang Yang, Yaoyu Huang, Yifei Ge, Xiangbao Yu, Li Liu, Li Xiang, Bin Liu, Chaoqing Gao, Changhua Liu, Yong Xu and 4 more

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Guang Yang *Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yaoyu Huang *Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yifei Ge *Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiangbao YuDepartment of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Li LiuDepartment of Nephrology, The Second People's Hospital of Hefei, Hefei, China.
Li XiangDepartment of Nephrology, The First People's Hospital of Changzhou, Changzhou, China.
Bin LiuDepartment of Nephrology, The People's Hospital of Wuxi, Wuxi, China.
Chaoqing GaoDepartment of Nephrology, Yijishan Hospital, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.
Changhua LiuDepartment of Nephrology, Northern Jiangsu People's Hospital, Yangzhou, China.
Yong XuDepartment of Nephrology, The Second People's Hospital of Huai'an, Huai'an, China.
Wenwen LiDepartment of Nephrology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, China.
Donghua LouNanjing Yike Baoda Pharmaceutical Technology Co., Ltd., Nanjing, China.
Tongqiang LiuDepartment of Nephrology, The Second People's Hospital of Changzhou, The Third Affiliated Hospital of Nanjing Medical University, Changzhou, Jiangsu, China.
Huijuan MaoDepartment of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: This phase II, open-label, prospective, multicenter study evaluated the efficacy and safety of intermittent intravenous doxercalciferol in treating secondary hyperparathyroidism (SHPT) in Chinese maintenance hemodialysis (MHD) patients. Methods: MHD patients aged 18 to 75 years with a serum intact parathyroid hormone (iPTH) level of 400 pg/mL or higher were enrolled and stratified into Mild, Moderate, and Severe groups based on baseline iPTH levels (400-599.99, 600-799.99, and ≥800 pg/mL, respectively). Patients received an initial dose of 4 μg of doxercalciferol three times weekly for 12 weeks, with subsequent dose adjustments to target iPTH levels of 150-300 pg/mL. Results: Of the 45 patients enrolled, 44 completed the study, with 20 patients in the Mild Group, 12 in the Moderate Group, and 12 in the Severe Group. The baseline iPTH level for the 44 patients was 655.05 (469.68, 831.40) pg/mL, which decreased to 269.90 (176.45, 365.65) pg/mL after 12 weeks of treatment. The overall mean percentage change in iPTH levels from baseline to week 12 was -55.45% ± 20.08%, with 86.4% of patients (38 cases) achieving a ≥30% reduction compared to baseline. At week 12, 80.00% of patients (16 cases) in the Mild Group had iPTH levels within the target range of 150-300 pg/mL or less than 150 pg/mL, compared to 41.76% (5 cases) in the Moderate Group and 33.33% (4 cases) in the Severe Group. All three groups showed a decrease in serum alkaline phosphatase (ALP) levels, with the Severe Group experiencing a statistically significant reduction (P = 0.001). The most common adverse event was hypercalcemia, occurring in 33.3% of patients (15 cases), with only 8.9% (4 cases) experiencing severe hypercalcemia (serum calcium >2.8 mmol/L). Hypercalcemia was resolved after dose reduction or discontinuation of the medication. Conclusion: Intermittent intravenous doxercalciferol effectively reduces iPTH levels in Chinese MHD patients, with a manageable safety profile. While hypercalcemia is a concern, the incidence of severe cases is not high. This study supports doxercalciferol as a potential treatment option for SHPT in Chinese MHD patients.

Indexed as

doxercalciferolefficacymaintenance hemodialysissafetysecondary hyperparathyroidism

Identifiers

PMID40290446
PMCPMC12021602

What Socratic holds

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LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.