ArticleKidney medicine2026
Safety, Pharmacokinetics, and Pharmacodynamics of SHR6508, a Calcium-Sensing Receptor Agonist, in Maintenance Hemodialysis Patients With Secondary Hyperparathyroidism: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study.
Article in Kidney medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rationale & Objective: Secondary hyperparathyroidism (SHPT) is a common health problem among patients receiving maintenance hemodialysis. SHR6508, an allosteric modulator of calcium-sensing receptors, was developed to reduce parathyroid hormone secretion among Chinese hemodialysis patients with SHPT. This study aimed to evaluate the safety, pharmacokinetics, and pharmacodynamics of SHR6508 administered intravenously. Study Design: This was a multicenter, randomized, double-blind, placebo-controlled single and multiple ascending dose phase 1 trial. Setting & Participants: This study was conducted at 18 sites in China. Hemodialysis patients who had serum intact parathyroid hormone (iPTH) concentration 400-1,300 pg/mL and corrected calcium ≥8.4 mg/dL (2.1 mmol/L) were enrolled. Interventions: Patients were randomized in a 4:1 ratio to receive SHR6508 or placebo by intravenous injection after hemodialysis. Outcomes: The primary outcomes were pharmacokinetic parameters and changes in iPTH and corrected calcium concentrations. Results: The plasma drug exposures (mean maximum plasma concentration, area under the concentration-time curve) increased proportionally with the dose after the administration of SHR6508. iPTH level declined markedly after a single dose of SHR6508 in all cohorts (5-30 mg). After multiple doses of 5-15 mg, the percentage of patients achieving a reduction in iPTH concentration ≥30% from baseline to week 2 (25.0%-90.9%) and week 4 (36.4%-100.0%) in the 5, 10, and 15 mg groups was higher than those observed in the placebo group (12.5% and 14.3%, respectively). Treatment-emergent adverse events, which were mostly mild or moderate, occurred in 41 (95.3%) SHR6508-treated patients and in all patients treated with placebo. Limitations: This study had a relatively small sample size and short treatment and follow-up period. Conclusions: SHR6508 showed promising efficacy and safety in Chinese hemodialysis patients with SHPT. A starting dose of 5 mg for titration was the best dose and will be used in the phase 2 study.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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 OpenQuestion graph.