ClinicalTrials.gg
Status unknownNCT04798092PARA-REINUpdated Dec 5, 2022

Impact of Parathyroidectomy on Renal Function

An observational study in Primary Hyperparathyroidism, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

Read the detailed description

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

Criteria are detailled in "Outcomes measures"

02

Conditions studied

  • Primary Hyperparathyroidism

Keywords

  • Primary Hyperparathyroidism
  • Renal function
03

In context

Hyperparathyroidism, Primary

104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's planned enrollment of 500 is above the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia

Exclusion criteria

Exclusion Criteria:

  • patients on dialysis
  • \< 15 ml/min
  • renal graft
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • Procedureparathyroidectomy

    surgical removal of parathyroid adenoma(s) with postoperative biological cure

06

What researchers measure

Primary outcomes

  1. Change in renal function

    glomerular filtration rate (CKD in mL/min)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

Secondary outcomes

  1. Change in calcium

    Blood calcium level (in mg/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  2. Change in parathormone

    Blood parathormone level (in ng/dL)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  3. Change in vitamin D

    Blood vitamine D level (in ng/mL)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  4. Change in urinary calcium

    Urine calcium level (in mg/24h)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  5. Change in insulin

    Fasting blood insuline level (in mUI/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  6. Change in glycemia

    Fasting blood glucose level (in g/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  7. Change in osteocalcin

    Blood osteocalcin level (in ng/mL)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  8. Change in bone alkaline phosphatases

    Blood bone alkaline phosphatases level (in microgr/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  9. Change in aldosterone

    Blood aldosterone level (in pg/mL)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  10. Change in renin

    Blood active renin (in pg/mL)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  11. Change in total cholesterol

    Blood total cholesterol (in gr/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  12. Change in HDL cholesterol

    Blood HDL Cholesterol (in gr/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  13. Change in LDL cholesterol

    Blood LDL Cholesterol (in gr/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  14. Change in triglycerides

    Blood triglycerides (in gr/L)

    Time frame: preoperative, postoperative at 3, 6, and 12 months

  15. CAC scoring on CT scan

    CAC score (actual value)

    Time frame: preoperative

07

Study locations

1 of 1 sites recruiting
  • CHRU Nancy
    Vandœuvre-lès-Nancy, Lorraine 54511, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04798092
Responsible party
Sponsor
First posted
Mar 15, 2021
Start date
Jan 1, 2010
Primary completion
Jan 2023 (estimated)
Completion
Jan 2023 (estimated)
Last update
Dec 5, 2022

Study contacts

laurent Brunaud
Contact
l.brunaud@chru-nancy.fr
Brunaud
principal investigator · CHU Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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