Phase 4 Chronic Kidney Disease Trial, Recruiting NCT04522622 Sponsor: Ditte Hansen Condition: Chronic Kidney Disease
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Phase 4 Chronic Kidney Disease Trial, Recruiting

NCT04522622
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 years or older.
  • People with advanced chronic kidney disease (stage 4 or 5, including those on dialysis), meaning the kidneys are working at 29% or less of normal function.
  • People whose bone density scan (DXA) shows significantly low bone density at the hip or spine, meeting specific score thresholds — or who have previously had a fragility fracture (such as a fracture of the spine, hip, forearm, upper arm, or ankle) confirmed by scan or X-ray. (The exact score thresholds differ for people taking prednisolone tablets long-term — confirm with trial site.)
  • People whose bone activity blood tests or bone biopsy results suggest a condition called "adynamic bone disorder," where the bones are not renewing themselves as actively as normal.

Who may not be able to join:

  • People with persistently high calcium levels in their blood.
  • People who have had a fracture in the last 6 months (re-screening may be possible after 6 months — confirm with trial site).
  • People who have previously had a condition called calciphylaxis (a serious condition involving calcium deposits in blood vessels).
  • People with thyroid problems that have not been adequately treated, in the opinion of their doctor (re-screening may be possible after treatment — confirm with trial site).
  • People currently taking a heart medication called digoxin.
  • People with Paget's disease or other conditions affecting bone metabolism.
  • People who have used certain bone-strengthening medications in the last 24 months, or specific medications called bisphosphonates in the last 12 months.
  • People with a current or past cancer diagnosis, except for certain types of non-melanoma skin cancer.
  • People who have had radiation therapy to any part of the skeleton.
  • People who have received a kidney transplant within the last 12 months.
  • People with low vitamin D levels in their blood (re-screening may be possible after levels are corrected — confirm with trial site).
  • People who are unable to use the teriparatide injection device.
  • People with significantly reduced liver function, based on specific blood test results.
  • People who are pregnant, breastfeeding, or are women of childbearing potential who are not using an approved form of contraception (such as an intrauterine device, or hormonal contraception including pills, implant, patch, vaginal ring, or injection).
  • People with a known allergy or sensitivity to teriparatide or any of its ingredients.
  • People who are unable to give informed consent.
  • People with other medical conditions or treatments that may interfere with the trial's results.
  • People with a history of drug or alcohol misuse.
  • People whom the local trial investigator considers unable to participate in a clinical study.
  • For people taking part in the optional bone biopsy procedure: those with an allergy to tetracycline antibiotics; those on blood-thinning medications that cannot be safely paused; or those with bleeding or clotting disorders.
  • For people taking part in optional pulse wave measurements: those with a heart rhythm condition called atrial fibrillation, or those with a heart valve condition called aortic stenosis.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Ditte Hansen, MD, PhD, Department of Nephrology, Herlev and Gentofte Hospital

Phone: +4528965887

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Ditte Hansen
Registry
ClinicalTrials.gov
Start date
15 December 2021
Est. completion
1 September 2026

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Changes in bone specific alkaline phosphatase (BSAP)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov