---
title: Subtotal Parathyroidectomy or Total Parathyroidectomy With Autograft in Chronic Kidney Disease Patients Under Dialysis
nct_id: NCT02464072
overall_status: UNKNOWN
phase: NA
sponsor: University of Sao Paulo General Hospital
study_type: INTERVENTIONAL
primary_condition: Hyperparathyroidism, Secondary
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02464072.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02464072"
ct_last_update_post_date: 2023-05-17
last_seen_at: "2026-05-12T07:12:45.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Subtotal Parathyroidectomy or Total Parathyroidectomy With Autograft in Chronic Kidney Disease Patients Under Dialysis

**Official Title:** Randomized Clinical Trial of Subtotal Parathyroidectomy or Total Parathyroidectomy With Immediate Heterotopic Autograft in Chronic Renal Disease Patients Stage V Under Dialysis

**NCT ID:** [NCT02464072](https://clinicaltrials.gov/study/NCT02464072)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 133
- **Lead Sponsor:** University of Sao Paulo General Hospital
- **Conditions:** Hyperparathyroidism, Secondary
- **Start Date:** 2012-07
- **Completion Date:** 2024-01
- **CT.gov Last Update:** 2023-05-17

## Brief Summary

This study evaluates the metabolic and clinical results of two well recognized and accepted surgical techniques in the management of severe hyperparathyroidism in patients under regular dialysis treatment.

## Detailed Description

Prospective randomized trial in the surgical management of severe hyperparathyroidism of chronic kidney disease stage V under dialysis. Patients will be randomized and they will be submitted to subtotal parathyroidectomy or total parathyroidectomy with immediate heterotopic autograft of 45 or 90 fragments of parathyroid tissue.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Stage V Chronic Kidney Disease patients under regular dialysis treatment with severe hyperparathyroidism requiring parathyroidectomy

Exclusion Criteria:

* patients refusing to participate in the study (they will receive standard surgery),
* patients unable to attend regular follow up consultations,
* patients with a successful kidney transplant at the moment of parathyroidectomy,
* patients submitted to any previous surgery of the thyroid or parathyroid,
* patients with chronic kidney disease but not under dialysis
```

## Arms

- **Subtotal Parathyroidectomy** (EXPERIMENTAL) — Patients will be submitted to subtotal parathyroidectomy. The intention is to leave a parathyroid remanent equivalent to two normal parathyroid glands in situ. The type of the operation is the intervention. No drugs or devices are tested.
- **Total Parathyroidectomy + 45 autografts** (ACTIVE_COMPARATOR) — Patients will be submitted to a total parathyroidectomy and 45 fragments of parathyroid tissue are grafted in the forearm. This is the current standard treatment at the institution for severe secondary hyperparathyroidism.The type of operation is the intervention itself. No new device or drug is involved.
- **Total Parathyroidectomy + 90 autografts** (EXPERIMENTAL) — Patients will be submitted to a total parathyroidectomy and 90 fragments of parathyroid tissue are grafted in the forearm. The type of operation is the intervention. No new device or drug is involved. .

## Interventions

- **Subtotal Parathyroidectomy** (PROCEDURE) — Subtotal parathyroid resection leaving the estimated mass of two normal parathyroid glands in situ. The type of operation is the intervention. No new device or drug is involved.
- **Total Parathyroidectomy + 45 autografts** (PROCEDURE) — Immediate autograft of 45 fragments of parathyroid tissue, after a total parathyroidectomy.This type of operation is the standard intervention at the institution at the moment. No new device or drug is involved.
- **Total Parathyroidectomy + 90 autografts** (PROCEDURE) — Immediate autograft of 90 fragments of parathyroid tissue, after a total parathyroidectomy.The type of operation is the intervention. No new device or drug is involved.

## Primary Outcomes

- **Survival** _(time frame: From the time of the operation until 5 years after intervention or death if it occurs before 5 years of follow up)_ — Five years survival after parathyroidectomy in an intention to treat analysis

## Secondary Outcomes

- **Metabolic Outcome 1: Serum Calcium (mg/dL)** _(time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up)_
- **Metabolic Outcome 2 : Serum Phosphorus (mg/dL)** _(time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up)_
- **Metabolic Outcome 3: Serum Alkaline Phosphatase (IU)** _(time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up)_
- **Metabolic Outcome 4: Serum Parathormone (pg/mL)** _(time frame: 1 to 60 months after intervention, Samples are taken according to regular follow up)_
- **Drug Requirement 1: Elemental Calcium Intake (g/day)** _(time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods.)_
- **Drug Requirement 2 Calcitriol intake (micrograms/day)** _(time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods)_
- **Drug Requirement 3: Sevelamer (mg/day)** _(time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods)_
- **Drug Requirement 4: Calcimimetics (mg/day)** _(time frame: 1 to 60 months after intervention, according to the dose prescibed in different periods)_
- **Clinical Outcome 1: Bone Pain in the VAS** _(time frame: Pre-operative (up to one week before the procedure) until 60 months after intervention)_
- **Clinical Outcome 2: Postoperative Skeletal Disease (Fractures/Brown tumor)** _(time frame: 1 to 60 months after intervention)_
- **Clinical Outcome 3: Quality of Life in the SF-36 Questionnaire** _(time frame: Preoperative (up to three days before the intervention) and until 60 months after intervention)_
- **Clinical Outcome 4: Additional Operation (Reoperation in Recurrent/Persistent Disease)** _(time frame: 1 to 60 months after intervention)_
- **Morbidity of the surgical procedures** _(time frame: intra-operative to 60 months)_

## Locations (1)

- University of Sao Paulo General Hospital, São Paulo, São Paulo, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of sao paulo general hospital|são paulo|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02464072.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02464072*  
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