Kidney DiseaseKiRiNCT06720532
Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-Trial
An observational study of Kidney Disease and Radiation Nephropathy, run by Hannah Schaefer at 1 site in Germany.
Trial summary
The goal of this observational study is to determine the impact of 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy (177Lu-PSMA-RLT) on kidney function over time. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Kidney Disease, Radiation Nephropathy, Metastatic Castrate Resistant Prostate Cancer (mCRPC)
- What is being tested?
- characterization of renal function., Handgrip strength test and Questionaires
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2024to 1 Aug 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All mCRPC patients starting with 177Lu-PSMA RLT at the Klinikum rechts der Isar
Who may be able to join
- Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).
Who cannot join
- Missing or incomplete informed consent.
- age below 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Schäfer/ Christoph Schmaderer contact
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar, München, Bavaria 81675
Munich
Hannah/Christoph Schäfer/Schmaderer, +498941408383, +498941405053, hannah.schaefer@mri.tum.de, christoph.schmaderer@mri.tum.de
About this study
Official title: 177Lu-PSMA-KiRi-trial
The goal of this observational study is to determine the impact of 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy (177Lu-PSMA-RLT) on kidney function over time. The main question it aims to answer is:
What is the absolute decline in estimated glomerular filtration rate (eGFR) in patients undergoing 177Lu-PSMA-RLT after 12 and 24 months?
Patients treated with 177Lu-PSMA-RLT will have their kidney function monitored before, during, and after therapy using routine markers like creatinine and cystatin C. Additional biomarkers and urine proteomics will be collected to identify early detection markers and risk factors for chronic kidney disease (CKD). Follow-up examinations will be conducted at regular intervals up to 5 years. The study also aims to correlate clinical risk factors and patient-reported outcomes with kidney insufficiency to assess the impact of therapy and identify vulnerable patient groups.
Read the detailed description
Patients with mCRPC treated at Klinikum rechts der Isar who are newly receiving therapy with 177Lu-PSMA-RLT will be included. To ensure data quality, standard operating procedures (SOPs) will be implemented for both technical measurements and data collection. Data entered into the registry will undergo double data verification against predefined rules for range and consistency with other data fields. This ensures the accuracy and reliability of the collected data. A detailed data dictionary will be maintained, describing each variable used in the registry, including its source, coding information (e.g., TNM staging system), and normal ranges if relevant. Patient reported outcomes (PROM) of cancer related symptoms and quality of life will be collected using standardized questionnaires.
Based on the power calculation, a total of 100 patients will be included in the study. These patients will be followed up for a period of up to 5 years to ensure comprehensive data collection and analysis.
- Conditions
- Kidney Disease, Radiation Nephropathy, Metastatic Castrate Resistant Prostate Cancer (mCRPC)
- Being tested
- characterization of renal function., Handgrip strength test, Questionaires
- Keywords
- mCRPC, 177Lutetium, 177Lu-PSMA, radioligand therapy
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
characterization of renal function.Diagnostic test
Blood and urine sample collection
Handgrip strength testDiagnostic test
Assess the peak isometric strength of the hand and forearm muscles, as well as their susceptibility to fatigue.
QuestionairesDiagnostic test
The questionnaires evaluate quality of life, psychological distress, fear of progression, frailty, pain, decision regret and treatment expectations.
| Study group | Role | What they receive |
|---|---|---|
| mCRPC Patients with 177Lutetium-PSMA RLT | Patients diagnosed with metastatic castration-resistant prostate carcinoma (mCRPC) undergoing initial treatment with 177Lutetium-PSMA radioligand therapy at the Klinikum rechts der Isar. Receives: Diagnostic Test: characterization of renal function.; Diagnostic Test: Handgrip strength test; Diagnostic Test: Questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic kidney disease frequency
The primary objective is to determine the long term frequency of chronic kidney disease as an expression of radiation nephropathy in patients treated with 177Lu-PSMA RLT, measured by the absolute decline in eGFR.
Measured: 2 years
Secondary outcomes (6)
Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy
Determination of the incidence of chronic kidney disease in long-term survivors following 177Lu-PSMA radioligand therapy (RLT), measured by the absolute decline in eGFR.
Measured: 5 years
Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD).
Detection of clinical risk factors that promote the development of chronic kidney disease (CKD).
Measured: 2 years
Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD.
Identification of renal biomarkers for the early detection of individuals at high risk of developing chronic kidney disease (CKD). Correlation of these biomarkers with the severity and timing of CKD onset. Measurement of established markers of glomerular injury, tubular damage, endothelial dysfunction, or functional impairment using ELISA.
Measured: 2 years
Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics.
Deciphering potential pathomechanisms of renal damage using established serum biomarkers and urine proteomics via targeted and untargeted analyses.
Measured: 2 years
Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs).
Measurement of quality of life, psychological distress, fear of progression, frailty, pain, decision regret, and treatment expectations using questionnaires.
Measured: 2 years
Longitudinal evaluation of potential radiation nephropathy.
Regular assessments of kidney function will be conducted over a period of 2 years. This will allow for the identification of the onset of kidney function impairments.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start5 Aug 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hannah Schaefer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hannah Schaefer, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720532
- Sponsor's protocol ID
- 2023-402-S-KK
- Acronym
- KiRi
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lu-PSMA-KiRi-trial
- ClinicalTrials.gov ID
- NCT06720532
- Acronym / sponsor ID
- KiRi / 2023-402-S-KK
- Conditions
- Kidney Disease, Radiation Nephropathy, Metastatic Castrate Resistant Prostate Cancer (mCRPC)
- Keywords
- mCRPC, 177Lutetium, 177Lu-PSMA, radioligand therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hannah SchaeferUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to determine the impact of 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy (177Lu-PSMA-RLT) on kidney function over time. The main question it aims to answer is:
What is the absolute decline in estimated glomerular filtration rate (eGFR) in patients undergoing 177Lu-PSMA-RLT after 12 and 24 months?
Patients treated with 177Lu-PSMA-RLT will have their kidney function monitored before, during, and after therapy using routine markers like creatinine and cystatin C. Additional biomarkers and urine proteomics will be collected to identify early detection markers and risk factors for chronic kidney disease (CKD). Follow-up examinations will be conducted at regular intervals up to 5 years. The study also aims to correlate clinical risk factors and patient-reported outcomes with kidney insufficiency to assess the impact of therapy and identify vulnerable patient groups.
Detailed description
Patients with mCRPC treated at Klinikum rechts der Isar who are newly receiving therapy with 177Lu-PSMA-RLT will be included. To ensure data quality, standard operating procedures (SOPs) will be implemented for both technical measurements and data collection. Data entered into the registry will undergo double data verification against predefined rules for range and consistency with other data fields. This ensures the accuracy and reliability of the collected data. A detailed data dictionary will be maintained, describing each variable used in the registry, including its source, coding information (e.g., TNM staging system), and normal ranges if relevant. Patient reported outcomes (PROM) of cancer related symptoms and quality of life will be collected using standardized questionnaires.
Based on the power calculation, a total of 100 patients will be included in the study. These patients will be followed up for a period of up to 5 years to ensure comprehensive data collection and analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCRPC Patients with 177Lutetium-PSMA RLT | – | Diagnostic Test: characterization of renal function., Diagnostic Test: Handgrip strength test, Diagnostic Test: QuestionairesPatients diagnosed with metastatic castration-resistant prostate carcinoma (mCRPC) undergoing initial treatment with 177Lutetium-PSMA radioligand therapy at the Klinikum rechts der Isar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All mCRPC patients starting with 177Lu-PSMA RLT at the Klinikum rechts der Isar
Key inclusion criteria (1 listed)
- Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).
Key exclusion criteria (2 listed)
- Missing or incomplete informed consent.
- age below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| characterization of renal function.Blood and urine sample collection | Diagnostic test | mCRPC Patients with 177Lutetium-PSMA RLT |
| Handgrip strength testAssess the peak isometric strength of the hand and forearm muscles, as well as their susceptibility to fatigue. | Diagnostic test | mCRPC Patients with 177Lutetium-PSMA RLT |
| QuestionairesThe questionnaires evaluate quality of life, psychological distress, fear of progression, frailty, pain, decision regret and treatment expectations. | Diagnostic test | mCRPC Patients with 177Lutetium-PSMA RLT |
Primary outcome
chronic kidney disease frequency
Time frame: 2 years
The primary objective is to determine the long term frequency of chronic kidney disease as an expression of radiation nephropathy in patients treated with 177Lu-PSMA RLT, measured by the absolute decline in eGFR.
6 secondary outcomes
Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy
Time frame: 5 years
Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD).
Time frame: 2 years
Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD.
Time frame: 2 years
Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics.
Time frame: 2 years
Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs).
Time frame: 2 years
Longitudinal evaluation of potential radiation nephropathy.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah Schäfer/ Christoph Schmaderer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease and Radiation Nephropathy, run by Hannah Schaefer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Schäfer/ Christoph Schmaderer (+49 - 89 4140 8383 ext. +498941405053, hannah.schaefer@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic kidney disease frequency (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.