The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density

NCT07171216 | Recruiting

• 1 other identifier: H-25038403
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of chronic kidney disease (CKD) in the adult population is estimated to 10%. CKD increases risk of bone fractures, cardiovascular disease and death. The main role of parathyroid hormone (PTH) is to regulate mineral metabolism, including the calcium and phosphate homeostasis. PTH increases as the kidney function declines, and at end stage kidney disease almost all patients have disturbances in the mineral metabolism. Decreasing bone mineral density is associated with risk of fracture, both in background population and in patients with CKD. For decades, treatment with activated vitamin D, phosphate binders, and calcium supplements has been used for patients with chronic kidney disease and elevated parathyroid hormone, but treatment targets have varied greatly over the years, reflecting the lack of randomized clinical trials with clinical important end points. The purpose of The REPAIR-CKD trial is to determine if treatment of hyperparathyroidism improves the bone mineral density in patients with chronic kidney disease. During this trial it will also be evaluated if it is feasible to obtain a difference in PTH levels when targeting two different levels of PTH. Further this trial will explore if a difference in PTH influences on arterial stiffness, muscle mass, muscle function, bone histology and health related quality of life.

Conditions

Chronic Kidney Disease Mineral and Bone Disorder

Keywords

parathyroid hormone; chronic kidney disease; randomized clinical trial; Activated vitamin D

Outcome Measures

Primary Outcomes (1)

• Difference in percent change in bone mineral density (BMD) between the treatment groups.

  Measured with DEXA-scan

  From baseline to final follow-up at 18 months

Secondary Outcomes (9)

• Difference in follow-up BMD between treatment groups

  From baseline to final follow-up at 18 months

• Difference in follow-up arterial stiffness between the treatment groups

  From baseline to final follow-up at 18 months

• Difference in follow-up muscle mass between the treatment groups

  From baseline to final follow-up at 18 months

• Difference in follow-up hand grip strenght between the treatment groups

  From baseline to final follow-up at 18 months

• Difference in follow-up 10 meter walk test between the treatment groups

  From baseline to final follow-up at 18 months

Other Outcomes (1)

• The feasibility to obtain a differential PTH level of at least 0.5 times the upper limit of normal between the two groups will be determined

  18 months

Study Arms (2)

PTH intensive target

EXPERIMENTAL

Intensive parathyroid hormone target (within interval of lower and upper normal limits = 2,0 - 8,5 µmol/L). In the intensive PTH target group, treatment will be initiated as soon as the PTH rise above the upper limit of normal. Participants in this group will receive treatment to lower PTH level (activated vitamin D, phosphate binder, native vitamin D and calcimetics). PTH will be measured as intact PTH with Atellica IM PTH assay at Herlev Hospital laboratory (normal range 2,0 - 8,5 µmol/L).

Other: Treat to target

PTH liberal target

EXPERIMENTAL

Liberal parathyroid hormone target (\< 5 x upper normal limit = 42,5 µmol/L). In the liberal PTH target group, treatment will not be initiated until PTH rise above five times the upper limit of normal. This is expected to be a small part of the participants. The cut-off for the liberal PTH target (\<5 x upper normal limit) was discussed in the national CKD-MBD group. It is chosen to allow the clinician initiate treatment if PTH reaches unusually high levels, no studies have focussed on PTH-targets before, consequently the cut-off is chosen as part of the pragmatic design.

Other: Treat to target

Interventions

Treat to target OTHER

Participants will receive treatment from a "toolbox" depending on the situation to reach the PTH target. Available medication is mirroring what is used in the outpatient clinic setting already (native vitamin D, activated vitamin D, phosphate binders, calcimetics).

PTH intensive target; PTH liberal target

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥50 years of age at screening
• CKD G4-5nonD (eGFR \< 30 mL/min/1.73m2) based on local laboratory assessment of serum creatinine and eGFR estimated by the CKD-EPI formula)
• Plasma PTH \> upper normal limit of local laboratory reference range (\> 8,5µmol/L) and/or treated with active vitamin D (Alphacalcidol) or calcimetics (Cinacalcet) initially
• Written informed consent

You may not qualify if:

• Patients who have received a kidney transplant
• Patients receiving treatment with specific anti-osteoporosis medication (denosumab/bisphosphonates) (because of the profound effect on calcium/phosphate fluxes and BMD)

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Nephrology, outpatient clinic, Herlev Hospital

Herlev, Capital Region, 2730, Denmark

RECRUITING

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MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency

Study Officials

• Ditte Hansen, Medical doctor, professor

  Department of Nephrology, Herlev Hospital

  STUDY DIRECTOR

Central Study Contacts

Freja S Hassager, Medical doctor

CONTACT

0045+22554707; freja.staehr.hassager.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators will be blinded to the primary endpoint (DEXA-scan and the analysis of this)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: Intervention in both treatment groups is used to reach a target of PTH (different levels in different groups, no pre-defined treatment)

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 12, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)